Wearable medical device

ABSTRACT

Wearable devices for providing therapy to a patient may include disposable or reusable treatment pads. The treatment pads may include electrodes and are configured to apply energy to various regions around the head and eyes. The treatment pads may provide therapy when the eyes are open or closed. The wearable device may include a battery and/or control circuitry for issuing therapy pulses through the electrodes.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/900,115, filed Jun. 12, 2020 and titled WEARABLE MEDICALDEVICE, which claims the benefit of and priority to U.S. Prov. Pat. App.No. 62/884,890, filed Aug. 9, 2019, titled WEARABLE MEDICAL DEVICE, andalso claims the benefit of and priority to U.S. Prov. Pat. App. No.62/861,658, filed Jun. 14, 2019, and titled WEARABLE MEDICAL DEVICE, thedisclosures of which are incorporated herein by reference.

TECHNICAL FIELD

The disclosure pertains to medical devices and more particularly towearable medical devices for treating or diagnosing areas of the bodyincluding the eyes and head, and methods for using such medical devices.

BACKGROUND

A wide variety of medical devices have been developed for medical useincluding, for example, medical devices utilized to treat or gatherdiagnostic information for medical conditions of the eye and head. Thesemedical devices may be used to provide therapy, such as electrotherapyor to gather information from various regions including the eyes andbrain. Of the known medical devices and methods, each has certainadvantages and disadvantages. There is an ongoing need to providealternative medical devices as well as alternative methods formanufacturing and using the medical devices.

SUMMARY

The present inventors have recognized a need for new and alternativedesigns for electrical therapy systems, particularly those configured toissue electrical therapy direct to the structures and tissues in andaround the eye including, for example and without limitation, neural,vascular, muscle and other tissue. A variety of particular uses for suchtherapy, and further alternatives, are described in greater detailbelow. For example, in some examples therapy may include both electricaland other modality of therapy, or electrotherapy in addition tobiologic, drug, transplantation, etc. Aims and benefits may include, forexample and without limitation, greater or enhanced comfort,wearability, the ability to engage in non-therapy activity whilereceiving therapy, predictability and repeatability of therapy itself,and/or simplicity, though not each embodiment described herein willaccomplish each such aim.

An illustrative and non-limiting example takes the form of a wearabledevice for providing therapy to a patient, the device comprising: aframe having a front piece and first and second arms extendingtherefrom, the front piece including a nosepiece, the first and secondarms extending from the front piece to first and second earpieces,respectively, which are shaped to contact and rest, at least partly, onthe ear of a user; at least one front electrode or electrode pad carriedon the front piece; and at least one earpiece electrode carried on atleast one of the earpieces.

Additionally or alternatively, the wearable device further comprises apower source and a control circuit coupled to the power source, thecontrol circuit configured to issue electrical signals through the frontelectrode or front electrode pad and the earpiece electrode to providetherapy to the eye of a user. Additionally or alternatively, the powersource may be either a rechargeable battery or a replaceable battery.Additionally or alternatively, the control circuit is contained in thefirst earpiece, and the power source is contained in the secondearpiece. Additionally or alternatively, the front piece comprises afirst expanded portion and a second expanded portion on either side ofthe nosepiece, the control circuit being contained in the first expandedportion and the power source being contained in the second expandedportion. Additionally or alternatively, the control circuit is containedin the nose piece. Additionally or alternatively, the power source iscontained in the nose piece. Additionally or alternatively, the at leastone front electrode or electrode pad is coupled to the front piece by anelectrode carrier configured to place the at least one front electrodeor electrode pad against the forehead of the user when worn.Additionally or alternatively, the at least one front electrode orelectrode pad is coupled to the front piece by an electrode carrierconfigured to place the at least one front electrode or electrode padagainst the upper eyelid of the user when worn.

Additionally or alternatively, the at least one front electrode isadjustable or moveable relative to the head of the user. Additionally oralternatively, the at least one front electrode is adjustable ormoveable relative to the frame. Additionally or alternatively, the atleast one front electrode is coupled to a spring to facilitate contactwith the patient's skin. Additionally or alternatively, the at least onefront electrode is carried on a pivoting or swivel prong or arm.Additionally or alternatively, the wearable device may be furthercharacterized by the omission of any electrode on the face of the userbelow the palpebral aperture.

Additionally or alternatively, the first and second earpieces aredetachable. Additionally or alternatively, the first and secondearpieces are shaped to at least partly wrap around the ears of theuser. Additionally or alternatively, the earpiece electrode is held on aflexible or moveable arm. Additionally or alternatively, the front pieceis configured to receive first and second lenses. Additionally oralternatively, the wearable device may further include an on/off switchactuatable by a user carried on one of the first and second earpieces.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: a frame having a front piece and first and second armsextending therefrom, the front piece including a nosepiece, the firstand second arms extending from the front piece to first and secondearpieces, respectively, which are shaped to contact and rest, at leastpartly, on the ear of a user; at least one front electrode or electrodepad carried on the front piece, the at least one front electrode beingsized and shaped for placement on the upper eyelid of a user.

Additionally or alternatively, the wearable device may further comprisea power source and a control circuit coupled to the power source, thecontrol circuit configured to issue electrical signals through the frontelectrode or front electrode pad to provide therapy to the eye of auser. Additionally or alternatively, the control circuit is contained inthe first earpiece, and the power source is contained in the secondearpiece. Additionally or alternatively, the front piece comprises afirst expanded portion and a second expanded portion on either side ofthe nosepiece, the control circuit being contained in the first expandedportion and the power source being contained in the second expandedportion. Additionally or alternatively, the control circuit is containedin the nose piece. Additionally or alternatively, the power source iscontained in the nose piece.

Additionally or alternatively, the at least one front electrode isadjustable or moveable relative to the head of the user. Additionally oralternatively, the at least one front electrode is adjustable ormoveable relative to the frame. Additionally or alternatively, the atleast one front electrode is coupled to a spring to facilitate contactwith the patient's upper eyelid. Additionally or alternatively, the atleast one front electrode is carried on a pivoting or swivel prong orarm.

Additionally or alternatively, the wearable device may be furthercharacterized by the omission of any electrode on the face of the userbelow the palpebral aperture.

Additionally or alternatively, the wearable device may further compriseat least one earpiece electrode carried on at least one of theearpieces.

Additionally or alternatively, the at least one front electrode isconfigured for placement on the eyelid of the user by having a length inthe range of about 1 to about 40 mm, and a width of about 1 to about 10mm.

Additionally or alternatively, the at least one front electrode isconfigured for placement on the eyelid of the user by having a length inthe range of about 10 to about 20 mm, and a width of about 2 to about 5mm.

Still another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: a frame having a front piece and first and second armsextending therefrom, the front piece including a nosepiece, the firstand second arms extending from the front piece to first and secondearpieces, respectively, which are shaped to contact and rest, at leastpartly, on the ear of a user; and at least one nosepiece electrodecarried on the nosepiece.

Additionally or alternative, the wearable device may further comprise atleast one second electrode and a moveable or pivotable arm coupled tothe frame, the arm carrying the at least one second electrode in aposition such that, when the frame is worn by a user, the arm can bemoved or pivoted to bring the at least one second electrode into contactwith the temple of the user. Additionally or alternatively, the wearabledevice may further comprise at least one second electrode and anelectrode carrier coupled to the front piece, the electrode carriercarrying the at least one second electrode in an adjustable manner suchthat, when the frame is worn by a user, the at least one secondelectrode is positioned on the forehead of the user. Additionally oralternatively, the wearable device may further comprise at least onesecond electrode and an electrode carrier coupled to the front piece,the electrode carrier carrying the at least one second electrode in anadjustable manner such that, when the frame is worn by a user, the atleast one second electrode is positioned on an upper eyelid of the user.Additionally or alternatively, the wearable device may further compriseat least one second electrode coupled to at least one of the earpieces.Additionally or alternatively, the wearable device may further comprisea power source and a control circuit coupled to the power source, thecontrol circuit configured to issue electrical signals between thenosepiece electrode and the at least one second electrode. Additionallyor alternatively, the wearable device may further comprise a powersource and a control circuit coupled to the power source, the controlcircuit configured to issue electrical signals via the nosepieceelectrode to deliver therapy to the eye of the user. Additionally oralternatively, the control circuit is contained in the first earpiece,and the power source is contained in the second earpiece. Additionallyor alternatively, the front piece comprises a first expanded portion anda second expanded portion on either side of the nosepiece, the controlcircuit being contained in the first expanded portion and the powersource being contained in the second expanded portion. Additionally oralternatively, the control circuit is contained in the nose piece.Additionally or alternatively, the power source is contained in the nosepiece.

Additionally or alternatively, the nosepiece electrode has a size in therange of about 1 to about 20 mm in length, and about 1 to about 20 mm inwidth.

Additionally or alternatively, the nosepiece electrode has a size in therange of about 4 to about 8 mm in width, and about 8 to about 15 mm inlength.

Yet another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: a housing configured to extend at least partially around thepatient's neck; at least one treatment pad configured to provide therapyto an eye of the patient, the treatment pad including at least oneelectrode and a connector electrically connecting the electrode on thetreatment pad to the housing; and wherein the housing includes acompartment configured to receive the treatment pad when not in use.

Additionally or alternatively, the housing further includes a returnelectrode configured to contact skin on the patient's neck when thehousing is disposed around the patient's neck. Additionally oralternatively, the housing contains control circuitry configured togenerate electrical pulses to output via at least the at least oneelectrode on the at least one treatment pad, and a power source forproviding electrical power to the control circuitry. Additionally oralternatively, the connector is retractable into the housing to therebydraw the at least one treatment pad into the compartment.

Another illustrative and non-limiting example takes the form of awearable device assembly for providing therapy to a patient, theassembly comprising: at least one treatment pad having an electrodeconfigured to provide therapy to an eye of a patient; a controllercontaining circuitry electrically connected to the treatment pad; and abattery; wherein the at least one treatment pad comprises a chamber forreceiving the battery therein.

Additionally or alternatively, the battery is rechargeable, and thedevice further comprises a charging unit for charging the rechargeablebattery while it is in the treatment pad. Additionally or alternatively,the at least one treatment pad includes first and second treatment padsconfigured to provide therapy to both eyes, wherein the wearable deviceassembly further includes a return electrode configured to be placed onthe patient's temple, neck, back, shoulder, back of hand, arm, behind anear, back, or chest. Additionally or alternatively, the at least onetreatment pad has a soft but resilient perimeter adapted to match theshape of a patient's eye socket and to aid in retaining the at least onetreatment pad in position once placed on the patient's eye.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: first and second treatment pads each including an electrodeconfigured to provide therapy to the patient's eyes; a frame configuredto be worn on the patient's face as eyeglasses, the frame including twoearpieces configured to extend along sides of the patient's face andover the patient's ears, and a bridge extending between the twoearpieces and over the patient's nose bridge, the frame including firstand second engagement members each configured to engage one of the firstand second treatment pads; and an adjustment member disposed on eachearpiece of the frame and configured to adjust a position of eachtreatment pad.

Additionally or alternatively, the adjustment member takes the form of ascrew, and the adjustment member is adapted to move a treatment padrelative to the frame to adjust the treatment pad position on thepatient when the frame is being worn.

Still another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: first and second treatment pads each including an electrodeconfigured to provide therapy to the patient's eyes; a frame configuredto hold the first and second treatment pads in a rotatable or slidingengagement; and a head strap coupled to the frame and configured tosecure the frame to the patient's face with the first and secondtreatment pads in contact with the patient's eyes.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: a mask configured to be worn on the patient's face, withfirst and second openings for the patient's eyes; and at least oneelectrode disposed on the mask adjacent one of the first and secondopenings, each electrode configured to provide therapy to one of thepatient's eyes.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: at least one disposable treatment patch each including atleast one electrode configured to provide therapy to the patient's eyes,the treatment patch configured to conform to contours of the patient'sface; and a frame configured to be worn on the patient's face aseyeglasses, the frame including first and second earpieces configured toextend along sides of the patient's face and over each of the patient'sears, and a bridge extending between the two earpieces and over thepatient's nose bridge, the frame including at least one engagementmember configured to releasably engage one of the at least onedisposable treatment patch. Additionally or alternatively, the wearabledevice further comprises a return electrode coupled to the frame, andthe device is configured to provide a monopolar therapy.

An illustrative and non-limiting example takes the form of a wearabledevice for providing therapy to a patient, the device comprising: aframe configured to be worn on the patient's face, the frame including afirst and second earpiece configured to extend along each side of thepatient's face and over the patient's ears, and a bridge extendingbetween the two earpieces and over the patient's nose; a plurality ofprongs extending from the frame, each prong having a contact configuredto contact skin of the patient's face when the frame is in position onthe patient's face; and a plurality of electrodes configured to providetherapy to the patient, one electrode disposed on each contact point.

Additionally or alternatively, at least some of the plurality of prongsare hinged and move between a first, contracted position in which theplurality of prongs are aligned with the frame, and a second, expandedposition in which the plurality of prongs extend at an angle from theframe and into contact with the skin.

Additionally or alternatively, for several of the preceding exampleshaving an earpiece, the wearable device may further comprise at leastone earpiece electrode carried on at least one of the earpieces.Additionally or alternatively, for several preceding examples, at leaston electrode is configured for placement on the upper eyelid of apatient. Additionally or alternatively, several preceding examples mayfurther comprise a power source and a control circuit coupled to thepower source, the control circuit configured to issue electrical signalsusing the electrodes on the first and second treatment pads.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: first and second treatment pads each including an electrodeconfigured to provide therapy to the patient's eyes; a frame configuredto be worn on the patient's nose, the frame extending between andconnecting the first and second treatment pads; and a first batterydisposed within the first treatment pad and a second battery disposedwithin the second treatment pad. Additionally or alternatively, thefirst and second batteries are rechargeable, wherein the wearable devicefurther comprises a charging unit configured to receive the first andsecond treatment pads to recharge the first and second batteries.Additionally or alternatively, the electrode within each of the firstand second treatment pads comprises at least two electrodes tofacilitate bipolar stimulus output.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: a treatment patch configured to be attached to the patient'sface; at least one electrode disposed on the treatment patch, eachelectrode configured to provide therapy to one of the patient's eyes;and a controller containing circuitry electrically coupled to thetreatment patch, the controller configured to control electrical therapydelivered by the electrode. Additionally or alternatively the wearabledevice further comprises a return electrode configured to be attached tothe patient's neck, shoulder, or chest.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising a frame having a front piece and first and second armsextending therefrom, the front piece including a nosepiece and carryingat least one front electrode or front electrode pad thereon, the firstand second arms extending from the front piece to first and secondearpieces, respectively, which are shaped to contact and rest, at leastpartly, on the ear of a user, at least one of the earpieces carrying anearpiece electrode, the device further a control circuit and a powersource, the control circuit configured to issue electrical signalsthrough the front electrode or front electrode pad and the earpieceelectrode to provide therapy to the eye of a user.

Additionally or alternatively, the front electrode or front electrodepad is adjustably coupled to the front piece to be held against theforehead of the user. Additionally or alternatively, the front electrodeor front electrode pad is adjustably coupled to the front piece to beheld against an upper eyelid of the user. Additionally or alternatively,the front electrode or front electrode pad is coupled to the nosepiece.Additionally or alternatively, the wearable device may be characterizedby the omission of any electrode on the face of the user below thepalpebral aperture. Additionally or alternatively, the power source maybe any of a single use, primary cell, rechargeable, or replaceablebattery.

Additionally or alternatively, the control circuit is contained in thefirst earpiece, and the power source is contained in the secondearpiece. Additionally or alternatively, at least one of the first andsecond earpieces are detachable. Additionally or alternatively, thefront piece comprises a first expanded portion and a second expandedportion on either side of the nosepiece, the control circuit beingcontained in the first expanded portion and the power source beingcontained in the second expanded portion. Additionally or alternatively,the control circuit is contained in the nose piece. Additionally oralternatively, the power source is contained in the nose piece.Additionally or alternatively, the first and second earpieces are shapedto at least partly wrap around the ears of the user. Additionally oralternatively, the earpiece electrode is held on a flexible or moveablearm. Additionally or alternatively, the front piece is configured toreceive first and second lenses. Additionally or alternatively, thewearable device may further comprise an on/off switch actuatable by auser and carried on one of the first and second earpieces.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: first and second treatment pads each including an electrodeconfigured to provide therapy to the patient's eyes; a frame configuredto be worn on the patient's nose, the frame extending between andconnecting the first and second treatment pads; and a first batterydisposed within the first treatment pad and a second battery disposedwithin the second treatment pad. Additionally or alternatively, thefirst and second batteries are rechargeable, wherein the wearable devicefurther comprises a charging unit configured to receive the first andsecond treatment pads to recharge the first and second batteries.

Another illustrative and non-limiting example takes the form of awearable device for providing therapy to a patient, the devicecomprising: a frame configured to be worn on the patient's face, theframe including a first and second earpiece configured to extend alongeach side of the patient's face and over the patient's ears, and abridge extending between the two earpieces and over the patient's nose;a plurality of prongs extending from the frame, each prong having acontact configured to contact skin of the patient's face when the frameis in position on the patient's face; and a plurality of electrodesconfigured to provide therapy to the patient, one electrode disposed oneach contact point.

An illustrative and non-limiting method example may comprise the stepsof a user donning any of the preceding wearable devices, or alternativesthereto, to place the one or more electrodes thereof at a desired,instructed, or therapeutic position, and activating circuitry of thewearable devices, when so provided, to deliver therapy. Still anotherillustrative and non-limiting example comprises any of the precedingwearable devices issuing therapy pulses via the electrodes thereof forpurposes of treating, reversing, preventing, arresting, or otherwiseaddressing a disease of the eye or surrounding tissues.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosure may be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1A shows a person wearing an illustrative medical device;

FIG. 1B shows various components of the medical device of FIG. 1A

FIG. 2 shows another illustrative medical device;

FIG. 3A shows a person wearing another illustrative medical device;

FIG. 3B shows various components of the medical device of FIG. 3A;

FIG. 4 shows various components of another illustrative medical device;

FIG. 5 shows various components of another illustrative medical device;

FIG. 6 shows various components of another illustrative medical device;

FIG. 7A shows a person wearing another illustrative medical device;

FIG. 7B shows various components of the medical device of FIG. 7A;

FIG. 8A shows a person wearing another illustrative medical device anddetails of that medical device;

FIG. 8B shows various pad configurations for the medical device of FIG.8A;

FIG. 9A shows a person wearing another illustrative medical device;

FIG. 9B shows details of the medical device of FIG. 9A;

FIG. 10A shows a person wearing another illustrative medical device;

FIG. 10B shows various components of the medical device of FIG. 10A;

FIG. 11A shows a person wearing another illustrative medical device;

FIG. 11B shows details of the medical device of FIG. 11A;

FIG. 12 shows a person wearing another illustrative medical device;

FIG. 13 shows a person wearing another illustrative medical device;

FIGS. 14A-14F illustrate another illustrative medical device;

FIGS. 15A-15B show another illustrative medical device;

FIG. 16 shows another illustrative medical device; and

FIGS. 17A-17D show another illustrative medical device.

While aspects of the disclosure are amenable to various modificationsand alternative forms, specifics thereof have been shown by way ofexample in the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit aspects of thedisclosure to the particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the disclosure.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about”, in thecontext of numeric values, generally refers to a range of numbers thatone of skill in the art would consider equivalent to the recited value(e.g., having the same function or result). In many instances, the term“about” may include numbers that are rounded to the nearest significantfigure. Other uses of the term “about” (e.g., in a context other thannumeric values) may be assumed to have their ordinary and customarydefinition(s), as understood from and consistent with the context of thespecification, unless otherwise specified.

The recitation of numerical ranges by endpoints includes all numberswithin that range, including the endpoints (e.g., 1 to 5 includes 1,1.5, 2, 2.75, 3, 3.80, 4, and 5). Although some suitable dimensions,ranges, and/or values pertaining to various components, features and/orspecifications are disclosed, one of skill in the art, incited by thepresent disclosure, would understand desired dimensions, ranges, and/orvalues may deviate from those expressly disclosed.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise. It isto be noted that in order to facilitate understanding, certain featuresof the disclosure may be described in the singular, even though thosefeatures may be plural or recurring within the disclosed embodiment(s).Each instance of the features may include and/or be encompassed by thesingular disclosure(s), unless expressly stated to the contrary. Forsimplicity and clarity purposes, not all elements of the disclosure arenecessarily shown in each figure or discussed in detail below. However,it will be understood that the following discussion may apply equally toany and/or all of the components for which there are more than one,unless explicitly stated to the contrary. Additionally, not allinstances of some elements or features may be shown in each figure forclarity.

Relative terms such as “proximal”, “distal”, “advance”, “withdraw”,variants thereof, and the like, may be generally considered with respectto the positioning, direction, and/or operation of various elementsrelative to a user/operator/manipulator of the device, wherein“proximal” and “withdraw” indicate or refer to closer to or toward theuser and “distal” and “advance” indicate or refer to farther from oraway from the user. In some instances, the terms “proximal” and “distal”may be arbitrarily assigned in an effort to facilitate understanding ofthe disclosure, and such instances will be readily apparent to theskilled artisan.

The term “extent” may be understood to mean a greatest measurement of astated or identified dimension, unless the extent or dimension inquestion is preceded by or identified as a “minimum”, which may beunderstood to mean a smallest measurement of the stated or identifieddimension. For example, “outer extent” may be understood to mean amaximum outer dimension, “radial extent” may be understood to mean amaximum radial dimension, “longitudinal extent” may be understood tomean a maximum longitudinal dimension, etc. Each instance of an “extent”may be different (e.g., axial, longitudinal, lateral, radial,circumferential, etc.) and will be apparent to the skilled person fromthe context of the individual usage. Generally, an “extent” may beconsidered a greatest possible dimension measured according to theintended usage, while a “minimum extent” may be considered a smallestpossible dimension measured according to the intended usage. In someinstances, an “extent” may generally be measured orthogonally within aplane and/or cross-section, but may be, as will be apparent from theparticular context, measured differently—such as, but not limited to,angularly, radially, circumferentially (e.g., along an arc), etc.

The terms “monolithic” and “unitary” shall generally refer to an elementor elements made from or consisting of a single structure or baseunit/element. A monolithic and/or unitary element shall excludestructure and/or features made by assembling or otherwise joiningmultiple discrete elements together.

It is noted that references in the specification to “an embodiment”, “anexample”, “some embodiments”, “some examples”, “other embodiments”,“other examples”, etc., indicate that the embodiment(s) or example(s)described may include a particular feature, structure, orcharacteristic, but every embodiment/example may not necessarily includethe particular feature, structure, or characteristic. Moreover, suchphrases are not necessarily referring to the same embodiment/example.Further, when a particular feature, structure, or characteristic isdescribed in connection with an embodiment/example, it would be withinthe knowledge of one skilled in the art to effect the particularfeature, structure, or characteristic in connection with otherembodiments/examples, whether or not explicitly described, unlessclearly stated to the contrary. That is, the various individual elementsdescribed below, even if not explicitly shown in a particularcombination, are nevertheless contemplated as being combinable orarrangeable with each other to form other additionalembodiments/examples or to complement and/or enrich the describedembodiment(s)/example(s), as would be understood by one of ordinaryskill in the art.

For the purpose of clarity, certain identifying numerical nomenclature(e.g., first, second, third, fourth, etc.) may be used throughout thedescription and/or claims to name and/or differentiate between variousdescribed and/or claimed features. It is to be understood that thenumerical nomenclature is not intended to be limiting and is exemplaryonly. In some embodiments/examples, alterations of and deviations frompreviously-used numerical nomenclature may be made in the interest ofbrevity and clarity. That is, a feature identified as a “first” elementmay later be referred to as a “second” element, a “third” element, etc.or may be omitted entirely, and/or a different feature may be referredto as the “first” element. The meaning and/or designation in eachinstance will be apparent to the skilled practitioner.

The following description should be read with reference to the drawings,which are not necessarily to scale, wherein similar elements indifferent drawings are numbered the same. The detailed description anddrawings are intended to illustrate but not limit the disclosure. Thoseskilled in the art will recognize that the various elements describedand/or shown may be arranged in various combinations and configurationswithout departing from the scope of the disclosure. The detaileddescription and drawings illustrate example embodiments/examples of thedisclosure. However, in the interest of clarity and ease ofunderstanding, while every feature and/or element may not be shown ineach drawing, the feature(s) and/or element(s) may be understood to bepresent regardless, unless otherwise specified.

Dry macular degeneration is an eye disorder typically affecting peopleover 50 years old. It may progress to wet macular degeneration whenblood vessels grow under the retina and leak. Although rare, maculardegeneration does occur in children and teenagers. Stargardt's diseaseis one form of macular degeneration found in younger people.Conventional treatment for early dry macular degeneration is throughnutritional and supplement therapy. Wet macular degeneration may betreated with laser photocoagulation and drug therapy, although thesetreatments have major limitations. Alternative treatments and devicesare needed.

Embodiments of wearable devices that may be used for providing therapyinclude electrical current, ultrasound, light, transcutaneous orpercutaneous infusion or injection devices, magnetic therapy devices,etc. The invention is directed to the various features that can beprovided for a wearable device. For conciseness the disclosure willdiscuss embodiments for providing electrotherapy to the eye viaelectrodes applied above or around the eye, however it should beunderstood that alternative forms of energy may be provided by thedevices and systems disclosed herein. In addition, while manyembodiments will be discussed in terms of energy delivery it isunderstood that the electrodes, devices and systems also can provide forreceiving information from the body and data collection. The wearabledevices may be useful for the treatment and/or diagnosis of a variety ofophthalmic conditions such as cataracts, diabetic retinopathy, maculardegeneration, refractive errors, glaucoma, corneal conditions includingcorneal lesions and abrasions including surgical wounds, inheritedretinal disease, presbyopia, retinitis pigmentosa, Stargardt's,CMV-retinitis, Best's disease, macular dystrophy, optic neuritis,ischemic anterior optic neuritis, Usher's syndrome, Leber's congenitalamaurosis, cone-rod dystrophy, cone dystrophy, choroideremia, gyrateatrophy, central retinal artery occlusion, central retinal veinocclusion, branch retinal artery occlusion, branch retinal veinocclusion, central serous chorioretinopathy, conditions amenable tonerve stimulation, including but not limited stimulating the facialnerve, such as dry eye, cystoid macular edema, ocular histoplasmosis,ocular toxoplasmosis, retinopathy of prematurity, amblyopia, strabismus,nystagmus, and any other ophthalmic, eye, or vision-related condition.In alternative embodiments, the systems disclosed herein may also beused to optimize or improve vision for eyes that are “normal” or havenot pathology.

A variety of electrical parameters for electrical output therapy aredisclosed herein. It should be understood that the apparatuses disclosedmay be used to deliver electrical therapy outputs having otherparameters than those specifically disclosed (such as at differentfrequency, wave shape, amplitude, pulse width, etc.). Such therapy canbe current controlled or voltage controlled, all within the scope of thepresent invention.

As will be described in greater detail below, FIG. 1A illustrates anexample of a wearable device 100 which may be utilized to providetherapy, such as electrotherapy to the eyes of a patient. Specifically,FIG. 1A illustrates the wearable device 100 having a housing 110 and apair of treatment pads 120 a, 120 b each attached to the housing 110 bya connector 130. The housing 110 may be configured to extend at leastpartially around the patient's neck. As shown in FIG. 1A, the housing110 may be U-shaped to surround the neck. For example, the housing 110may extend from one collarbone around the back of the neck and to theopposite collarbone.

The housing 110 may include at least one compartment configured toreceive the treatment pads 120 a, 120 b when not in use. As shown inFIG. 1B, in some examples, the compartment may include end caps 112disposed on the free ends of the U-shaped housing 110. Each end cap 112may have a recess configured to hold one of the treatment pads 120 a,120 b. The end caps 112 may have a hinge connection 115 to the housing110, as shown in FIG. 1B. In other examples, the end caps 112 may have afriction fit or snap fit with the housing 110. In some examples, theconnector 130 may be retractable within the housing 110 when thetreatment pads 120 a, 120 b are disposed in the end caps 112. When theend caps 112 are opened, the treatment pads 120 a, 120 b may be pulledout, extending the connector 130 so the treatment pads 120 a, 120 breach the eyes when the housing 110 is in place around the neck, asshown in FIG. 1A. In some examples, the treatment pads 120 a, 120 b mayretract against or into the end of the housing 110. In some examples,the treatment pads may be absent and the user may instead use a set ofgoggles or a glasses-type frame that carries therapy electrodes thereon.

The housing 110 may include a return electrode 118 configured to contactskin on a portion of the patient's body spaced apart from the eyeregion. As shown in FIG. 1B, the return electrode 118 may be positionedon an inner surface of the base of the U-shaped housing 110 such that itcontacts the back of the patient's neck when the housing 110 is worn bythe patient as illustrated in FIG. 1A. However, it should be understoodthat the return electrode 118 may be placed on any portion of thepatient's body spaced apart from the eye area, including the temple, onor behind the ear, mouth, neck, shoulder, chest, back of the hand, arm,etc.

Each treatment pad 120 a, 120 b may include at least one electrode 122configured to provide therapy to an eye region of the patient. Theconnector 130 may electrically connect the electrode 122 on eachtreatment pad 120 a, 120 b to circuitry inside the housing 110. Thetreatment pads 120 a, 120 b may each include a treatment patch 124disposed over the electrode 122. In some examples, the treatment pads120 a, 120 b may include a permanent treatment patch 124 that isreusable and defines a cleanable surface. In other examples, thetreatment pads 120 a, 120 b may include a removable, disposabletreatment patch 124. The treatment patch 124 may include a biocompatibleadhesive configured to adhere the treatment pads 120 a, 120 b to thepatient's skin. In some examples, the treatment patch 124 may includeadhesive on both sides, the first side to adhere to the electrode 122and treatment pad 120 a, 120 b, and the second side to adhere to thepatient's skin. A plurality of disposable treatment patches 124 may beprovided, for example, in the end caps 112, another region of thehousing 110, or in a separate container. The treatment patch 124 mayinclude a window for allowing electrode 122 to contact tissue. In otherexamples, the treatment patch 124 itself may define the electrode 122.For example, the treatment patch 124 may be conductive in nature, suchas by using a conductive hydrogel or conductive adhesive to both holdthe treatment patch 124 on user tissue and to conduct currenttherethrough. In some examples, the electrode 122 may be attached to asurface of the treatment patch 124 or be embedded within the treatmentpatch 124. In some examples, the treatment patch 124 may be made of agel or padded material to provide a cushioned surface against the skin.

The housing 110 contains electronics for providing a therapy output. Forexample, a microcontroller, state machine, discrete logic, one or moreapplication specific integrated circuits (ASICs), various discretecomponents (resistors, diodes, switches, transistors, capacitors,inductors), amplifiers, etc. may be provided as the electronics of thesystem. In an example, the electronics may include a microcontrollercoupled to communication circuitry (such as Bluetooth or other RFwireless, inductive, or optical circuitry) to receive control signals,programming information, and to provide diagnostic and device historydata. The microcontroller may be coupled memory elements, such as aflash memory chip or the like, or other suitable volatile ornon-volatile memory, to store program instructions, therapy parameters,diagnostic and history information. The microcontroller may be coupledto and control the operation of sensing circuitry (such as a buffer,sampling, amplifier, filter, and analog-to-digital conversion circuitry)as well as output circuitry which may include a voltage source, acurrent source, a transducer (for example to provide an ultrasound orother mechanical output as well as to control a pump or infusionapparatus that delivers a chemical or biological substance), and/orlight generating circuitry (such as a VCSEL, LED, laser diode, or othercircuit or component that converts electricity to light. Themicrocontroller may be replaced by a microprocessor or by a statemachine, if desired.

In some examples, the housing 110 may include at least one rechargeablebattery configured to power the pulse generator or control circuitry,which in turn provides therapeutic signals to the electrode 122 on eachtreatment pad 120 a, 120 b. A charging port 116 such as a USB chargingport may be provided on the housing 110 to allow for recharging thebattery. In some examples, rather than a rechargeable battery, areplaceable battery may be provided, both in the embodiment of FIG. 1 aswell as in any of the other examples that follow.

The housing 110 may also include an on/off switch 114 to activate theelectrodes 122. In some examples, a separate control unit 140 may beused with the wearable device 100. The control unit 140 may have a wiredor wireless (cellular phone, Bluetooth, etc.) connection to the housing110 and may be used by the physician to set and/or modify treatmentparameters for the electrodes 122.

In use, the patient places the housing 110 around his or her neck withthe return electrode 118 in contact with the skin on the back of theneck. The end caps 112 are opened and the treatment pads 120 a, 120 bare removed and the connectors 130 extended. In some examples, a newtreatment patch 124 may be disposed over the electrode 122 and thetreatment patch 124 placed over the eyelid, as shown in FIG. 1A. The twotreatment pads 120 a, 120 b may be used together to treat both eyessimultaneously, or a single treatment pad 120 may be used to treat onlyone eye, while the other treatment pad 120 remains in the end cap 112 ofthe housing 110. The on/off switch 114 is moved to the “on” position andthe electrode 122 delivers therapy to one or both eyes. Alternatively,the “on” position may put the system into an active mode that isactivated to deliver energy by a separate command from a remote controlor other activation system. Prior to delivering energy the system mayinclude a pre-check that confirms appropriate impedance prior to therapydelivery.

The parameters of the therapy may be dictated by a physician through thecontrol unit 140. The control unit may alternatively or in addition beoperated by the patient to deliver pre-determined therapy parametersthat have been programmed by the physician on the control unit 140 orfrom a remote programmer not pictured. The physician may program thetreatment parameters during an office visit. Treatment may be fixed bythe physician, or may be modifiable by the patient within parameters setby the physician. Once the treatment session is complete, the patientremoves the treatment pads 120 from the eyes, removes and disposes ofthe treatment patches 124, and returns the treatment pads 120 to the endcaps 112 for storage. The batteries within the housing may be rechargedby plugging a USB charging cord into the charging port 116. In additionor in the alternative, the batteries may be replaceable. In exampleswith a permanent treatment patch 124, it may be cleaned after each usewith a disinfectant and/or wetted such as by adding a saline solution orhydrogel before each use to aid in conducting current to and throughuser tissue.

Therapy may be provided in a monopolar fashion, with current flowingbetween the electrodes 122 and the return electrode 118, or in bipolarfashion, with current flowing between two of electrodes 122. In anotherexample, the electrodes 122 may include two or more discrete contactseach, that is, in the form of a compound electrode having a plurality ofseparately addressable electrical nodes in close proximity to oneanother.

A variety of examples of electrical subsystems that may be implementedin addition to or in place of that just discussed may be found in any ofU.S. Pat. No. 7,251,528 and/or US PG Pub. No. 20200101290), U.S. patentapplication Ser. Nos. 16/697,689, and 16/844,421, and/or U.S. Prov. Pat.App. Nos. 62/867,421, and/or 62/873,450, the disclosures of which areincorporated herein by reference.

FIG. 2 shows another wearable device 200 including a housing 210 andtreatment pads 220 connected to the housing 210 by connectors 230. Thehousing 210 as shown includes an adhesive pad 219 surrounding the returnelectrode 218 to aid in keeping the return electrode 218 in contact withthe skin when the housing 210 is disposed around the patient's neck. Inthe example shown in FIG. 2 , the housing includes recesses 212 adjacentthe free ends of the U-shaped housing 210. The recesses 212 may beconfigured to receive the treatment pads 220 when not in use. Theconnectors 230 may be retractable within the housing 210 when thetreatment pads 220 are disposed within the recesses 212. The treatmentpads 220 may be received within the recesses 212 by a snap fit orfriction fit, with the electrodes 222 facing the housing 210 to protectthe electrodes 222. As with the example shown in FIG. 1B, the treatmentpads 220 may have a permanent treatment surface or may be used withremovable and disposable treatment patches as described above. Thewearable device 200 may be used as described above with regard towearable device 100. The housing 210 may contain electronics and a powersource similar to those described above relative to housing 110.

FIG. 3A illustrates another example of a wearable device 300 forproviding therapy to a patient. The wearable device 300 may include atreatment pad 320 with an adjustable head strap 302 and a connector 330connectable to a controller 340 (shown in FIG. 3B) containing circuitryelectrically connected to the treatment pad 320. The controller 340 maycontain electronics similar to those described above relative to housing110. In some examples, the treatment pad 320 may instead contain theelectronics, and the controller 340 may be omitted and/or the connector330 tethering the controller 340 to the treatment pad 320 may beomitted, such that the controller 340 serves as a wireless remotecontrol.

The wearable device 300 may have a single treatment pad 320 and be usedto treat only one closed eye at a time, as shown in FIG. 3A. Thiswearable device 300 may allow the patient to keep the uncovered eyeopen. The treatment pad 320 may include an electrode 322 configured toprovide therapy to an eye of a patient. More than one electrode 322,such as having at least two separately addressable electrodes, may beprovided on a device 300. A treatment patch 324 may be disposed over theelectrode 322, similar to the treatment pad 120 described above. In someexamples, the treatment patch 324 may be a gel patch. The treatmentpatch 324 may be permanent, and may be disinfected after each use, orwetted prior to use such as by adding a saline or hydrogel thereto, orthe treatment patch 324 may be removable and disposable. A disposabletreatment patch 324 may be attached to the treatment pad 320 withadhesive.

The treatment pad 320 may also include a rechargeable battery (notshown) and may be charged by placing the treatment pad 320 on a chargingunit 326. The charging unit 326 may be an induction charging unit 326plugged into a standard wall outlet and may include a lid 328 to protectthe treatment patch 324 during charging. In some examples, thecontroller 340 may include a touch pad for programming and monitoringthe treatment pad 320. In addition to or alternative to the controller340, a remote control device 342 may be used to operate the treatmentpad 120. The remote control device 342 may be wireless, operating on acellular signal, Bluetooth, or other wireless control signal.

In another example, shown in FIG. 4 , the wearable device 400 includesfirst and second treatment pads 420 a, 420 b, each having a connector430 connecting the treatment pads 420 to a return electrode 418. One orboth of the treatment pads 420 a, 420 b may contain electronics similarto those described above relative to housing 110. In one example, arechargeable battery may be contained on one of the treatment pads 420a, and electrically coupled to the other of the treatment pads 420 bwhich houses the electronics for the system, thereby distributing theweight of the battery and electronics across the two pads 420 a, 420 b.

The return electrode 418 may be configured to be placed on the anyportion of the patient's body spaced apart from the eye area, includingthe temple, on or behind the ear, mouth, neck, back, shoulder, chest,back of the hand, arm, etc. Each of the first and second treatment pads420 a, 420 b may include a treatment patch 424 for contacting thepatient's eyelid. The treatment patch 424 may be a gel patch. In someexamples, the treatment pads 420 a, 420 b and the return electrode 418may have an adhesive backing 421 for attaching the treatment pad 420 a,420 b to the eyelid. Each treatment pad 420 a, 420 b may include anelectrode (not shown) configured to provide therapy to the eye. Theelectrodes may be disposed under the treatment patch 424, as describedabove with regard to treatment pads 120 a, 120 b and shown in FIG. 1B.

The wearable device 400 may have a head strap 402 connecting the twotreatment pads 420 a, 420 b around the back of the head, and a strap 404extending between the eyes to provide eye to eye axis adjustability.Both straps 402 and 404 can be a fixed size or be adjustable. Thewearable device 400 may include a controller, charging unit, and remotecontrol device as described above for the wearable device 300.

A wearable device 500 for providing therapy that looks similar to a pairof eyeglasses is shown in FIG. 5 . The wearable device 500 may includefirst and second treatment pads 520 configured to provide therapy to thepatient's eyes, and a frame 510 configured to be worn on the patient'sface as eyeglasses. The frame 510 may include two earpieces 512configured to extend along the sides of the face and over the ears, anda bridge 515 extending between the earpieces 512 and over the bridge ofthe nose. The treatment pads 520 may include treatment patches 524configured to contact the closed eyelids. In some examples, thetreatment patches 524 may be padded or may be gel pads. Each treatmentpad 520 may include an electrode 522 disposed under the treatment patch524, configured to provide therapy to the eye.

In order to provide adjustability so the treatment patches 524 are incontact with the eyelids when the wearable device 500 is placed on thepatient with the earpieces 512 over the ears and the bridge 515 on thebridge of the nose, each earpiece 512 may include an adjustment member511. The adjustment member 511 may be configured to move the treatmentpad 520 toward and away from the eyelid relative to the frame 510,particularly the bridge 515. The adjustment member 511 may include anengagement member 513 configured to engage one of the treatment pads520. In some examples, the engagement members 513 may engage thetreatment pads 520 in a snap fit. As shown in FIG. 5 , treatment pads520 may each have a snap fit region 523 on an outer edge that isconfigured to couple to the engagement members 513 with a snap fit. Thetreatment pads 520 may be moved towards or away from the eyes, forexample, by turning a screw 516, thereby adjusting the position of thetreatment pad 520 to move it toward or away from the patient's face. Theadjustability of the position of the treatment pads 520 allows thecontrol of the desired level of contact with the eyelids, ensuringadequate electrical stimulation of underlying tissue from the electrodewithin the treatment pad 520, without undue pressure being applied tothe eyes. In some embodiments, the system may be configured to run animpedance check and an indicator (for example, sound or light) may beprovided to indicate when the appropriate level of pressure is beingapplied to provide a desired level of impedance for the energydelivered.

The frame 510 may contain electronics similar to those described aboverelative to housing 110. The wearable device 500 may include arechargeable battery disposed within the frame 510. A charging port (notshown) similar to charging port 116 shown in FIG. 1B may be disposed onthe frame 510, for example on one of the earpieces 512, to recharge thebattery. In some examples, a return electrode (not shown) may beprovided as a contact point on the frame 510, such as on one or both ofthe earpieces 512, and located to contact the patient behind the ear. Inother examples, one or more return electrodes may be placed on anyportion of the patient's body spaced apart from the eye area, includingon the ear, temple, mouth, neck, back, shoulder, chest, back of thehand, arm, etc.

Another wearable device 600 for providing therapy that looks similar toa pair of eyeglasses or goggles is shown in FIG. 6 . The wearable device600 may include first and second treatment pads 620 configured toprovide therapy to the patient's eyes, and a frame 610 configured to beworn on the patient's face as eyeglasses. The wearable treatment device600 may include an adjustable head strap 602 coupled to the frame 610and configured to secure the frame 610 to the patient's face with thefirst and second treatment pads 620 in contact with the patient's eyes.Alternatively, the adjustable head strap may be supplanted by an earpiece 512 shown in FIG. 5 . The frame 610 may include a center bridge615 between two pad-holding regions 611. The frame 610 may be configuredto hold the first and second treatment pads 620 in a rotatable orsliding engagement. The rotatable engagement may be provided by a hingedisposed on the pad-holding region 611 and on the treatment pad 620,allowing the treatment pad 620 to be rotated up and away from theeyelid, as shown by arrow 650. The sliding engagement may be provided bya groove or channel 613 disposed on the inner surface of the pad-holdingregion 611 of the frame 610. The channel 613 may be configured toreceive the edge 621 of the treatment pad 620 in a sliding friction fit.The treatment pad 620 may be removed from the frame 610 by sliding thetreatment pad 620 downward, as shown by arrow 652.

The treatment pads 620 may include treatment patches 624 configured tocontact the eyelids. In some examples, the treatment patches 624 may bepadded or may be gel pads. Each treatment pad 620 may include anelectrode 622 disposed under the treatment patch 624, configured toprovide therapy to the eye. The treatment pads 620 may be removable andexchangeable, and the treatment patches 624 may be removable anddisposable, or they may be permanently attached to the treatment pads620. The treatment pads 620 may include multiple electrode contacts, forexample located in a relative superior and position (i.e., onecontacting the upper eyelid and one the lower, respectively) to providebipolar energy delivery. In some examples, one or more return electrode(not shown) may be provided on the frame 610, head strap 602, or as aseparate element electrically coupled to the device 600. The returnelectrode may be located to contact the patient on or behind the ear oron the temple. In other examples, one or more return electrodes may beplaced on any portion of the patient's body spaced apart from the eyearea, including on or near the mouth, neck, back, shoulder, chest, backof the hand, arm, etc.

The frame 610 may contain electronics similar to those described aboverelative to housing 110. The wearable device 600 may include arechargeable battery disposed within the frame 610. A charging port (notshown) similar to charging port 116 shown in FIG. 1B may be disposed onthe frame 610 to recharge the battery.

FIG. 7A illustrates another example of a wearable device 700 forproviding therapy to a patient. The wearable device 700 may include atreatment mask 720 with an adjustable head strap 702 and a connector 730connectable to a controller 740 (shown in FIG. 7B) containing circuitryelectrically connected to the treatment mask 720. The treatment mask 720may include first and second openings 721 for the patient's eyes, andmay have a single electrode 722 a adjacent one of the openings 721 toprovide therapy to a single eye. In other examples, an electrode 722 a,722 b may be disposed adjacent each of the first and second openings 721to provide therapy to both eyes. The single electrode 722 a may bepositioned over the lower eyelid or over the upper eyelid (722 b). Whenmultiple electrodes 722 a, 722 b are present, they may both bepositioned over the lower eyelid, over the upper eyelid, or one over thelower eyelid and one over the upper eyelid. The electrode 722 a, 722 bmay be disposed on the surface of the treatment mask 720 or may bedisposed within layers forming the treatment mask 720. In some examples,the electrode 722 a, 722 b may be used in a bipolar manner, such as byhaving more than one electrode adjacent each eye. In other examples, theelectrode 722 a, 722 b may be used in a monopolar fashion, and a returnelectrode (not shown) may be disposed on the connector 730 andconfigured to be placed on any portion of the patient's body spacedapart from the eye area, including the temple, on or behind the ear,mouth, neck, back, shoulder, chest, back of the hand, arm, etc., asdescribed above for return electrode 418 in FIG. 4 .

The controller 740 may contain electronics similar to those describedabove relative to housing 110. The controller 740 may be configured tocontrol electrical therapy delivery by the electrode 722. In someexamples, the controller 740 may include a wall plug. In other examples,the controller 740 includes a battery, either a disposable battery or arechargeable battery and a charging port. The controller 740 may allowthe patient to turn the treatment mask 720 on and off. In some examples,the controller 740 may include wireless connectivity to a patient's orphysician's cellular phone or tablet 742. The connectivity may bethrough a cellular signal, Bluetooth, or other wireless signal. In someexamples, the mask 720 or headband 702 may instead carry theelectronics, similar to those described above relative to housing 110.

The wearable device 700 may be used to treat the eyes while open, whichmay provide for an improved and more convenient experience for thepatient. In some examples, the treatment mask 720 may include padded,foam, or gel regions. For example, the entire treatment mask 720 mayinclude a foam, padded, or gel frame 710, to provide additional comfortto the patient. The treatment mask 720 may be formed from a flexiblematerial such as fabric or polymer. In some examples, the treatment mask720 may include a rigid or semi-rigid nose cover 705 configured to fitover the patient's nose. The nose cover 705 may aid in maintaining theflexible treatment mask 720 in the desired position on the patient'sface. The nose cover 705 may be made of flexible metal or flexiblepolymer to provide a semi-rigid nose cover 705. As used herein“semi-rigid” encompasses materials having a rigidity greater than thematerial used to make the flexible treatment mask 720. In some examples,the nose cover 705 may be malleable, such that the patient may mold thenose cover 705 to their nose, providing a custom fit to the wearabledevice 700.

Another example of a wearable device 800 for providing therapy is shownin FIG. 8A. The wearable device 800 may include at least one disposabletreatment patch 824 configured to provide therapy to the patient's eyes,and a frame 810 configured to be worn on the patient's face aseyeglasses. The frame 810 may include two earpieces 812 configured toextend along the sides of the face and over the ears, and a bridge 815extending between the earpieces 812 and over the bridge of the nose.

The treatment patch 824 may be configured to contact the skin around theeyes while the eyes are open. In some examples, the treatment patch 824may include a lower region 826 configured to be placed on the skin belowthe eye and an upper region 828 configured to be placed on the uppereyelid. In some examples, each of the lower region 826 and upper region828 may include a separate electrode 822 a, 822 b. In other examples,the entire treatment patch 824 may define a single electrode. Thewearable device 800 may include an electrical connector 830 connectingthe one or more electrode 822 a, 822 b to a controller (not shown). Insome examples, the treatment patch 824 may include a first lower region826 and first upper region 828 configured to surround a first eye, and asecond lower region 826 and second upper region 828 configured tosurround a second eye, with a bridge region 829 connecting the first andsecond lower regions 826 and first and second upper regions 828. Thebridge region 829 may be configured to extend over the bridge of thenose. In some examples, the treatment patch 824 may be removablyconnected to the frame 810 with a snap fit, for example with a pad snapelement 823 receiving a portion of the bridge 815 of the frame 810.

In some examples, the electrode 822 a, 822 b may be used in a monopolarmanner, and the wearable device 800 may further include a returnelectrode 818 coupled to the earpiece 812 of the frame 810. In oneexample, the return electrode 818 may be provided as a contact point onthe earpiece 812, and located to contact the patient behind the ear. Inone example, the return electrode 818 may include an electricalconnector 830 coupling the return electrode 818 to a first magnet 825that may engage a second magnet 817 on the earpiece 812. The returnelectrode 818 may be coupled to the earpiece 812 such that the returnelectrode 818 may be placed on the patient's temple. In someembodiments, two return electrodes 818 may be provided, one on eitherearpiece 812. In other examples, the return electrode 818 may be placedon any portion of the patient's body spaced apart from the eye area,including on or behind the ear, mouth, neck, back, shoulder, chest, backof the hand, arm, etc. The frame 810 may contain electronics similar tothose described above relative to housing 110.

In some examples, the treatment patch 824 may be padded or may be gelpads. Each treatment patch 824 may be flexible and may have an adhesivebacking to allow the patient to easily affix the treatment patch 824onto the skin in the area to be treated, and to follow the contours ofthe face. In some examples, the treatment patch 824 may be made offabric or a flexible polymer, and the electrode 822 a, 822 b may bedisposed on the surface or embedded within the treatment patch 824. Thetreatment patches 824 a-824 g may be disposable and may have a varietyof shapes and sizes, as shown in FIG. 8B. Regardless of the shape orsize, each treatment patch 824 a-824 g may have an electrical connector830 coupling the electrodes of the treatment patch 824 a-824 g to acontroller. The treatment patches 824 a-824 g may be coupled to aportion of a frame 810, such as with a magnet, as discussed above withregard to the return electrode 818. In other examples, the treatmentpatches 824 a-824 g may be used without a frame, and simply adhered tothe skin via the adhesive backing on the patch. The treatment patches824 a-824 g may be used with a separate return electrode, or theelectrode in the treatment patches 824 a-824 g may have two separatecontacts for use in a bipolar fashion. In some examples a singletreatment patch 824 b, 824 b, 824 c, 824 d may be used, while in otherexamples, two treatment patches 824 e, 824 f, 824 g may be used. Varioussizes and shapes of treatment patches 824 a-824 g may be used tocustomize the treatment area desired. Examples of areas where thetreatment patches 824 a-824 g may be placed include, without limitation,the upper and lower eyelids, extending between the temporal (lateral)canthus and the nasal (medial) canthus. The treatment patches 824 a-824g may extend across the upper eyelid crease and upper lid fold, lowereyelid crease, malar fold, infraorbital crease, nasojugal crease, andnasofacial sulcus.

FIGS. 9A and 9B illustrate another example wearable device 900 forproviding therapy, particularly advantageous for therapy while thepatient's eyes remain open. The wearable device 900 may include firstand second treatment patches 924 configured to provide therapy to thepatient's eyes, and a frame 910 configured to be worn on the patient'sface as eyeglasses. The frame 910 may include two earpieces 912configured to extend along the sides of the face and over the ears,lateral frame extensions 917 coupled to the treatment patches 924 andextending around the eyes, and a bridge 915 extending between thelateral frame extensions 917 and over the bridge of the nose. Thetreatment patches 924 may be configured to contact the skin below theeyes, as shown in FIGS. 9A and 9B, allowing the patient to more easilyopen his or her eyes during treatment. It will be appreciated that inthe alternative the treatment patch 924 could alternatively or inaddition be located above the eye by moving the lateral frame extension917 above the eye.

The wearable device 900 may further include a controller 940 andelectrical connectors 930 coupling electrodes 922 on the treatmentpatches 924 to electrical circuitry in the controller 940. Thecontroller 940 may contain electronics similar to those described aboverelative to housing 110. Alternatively, the frame 910, for example, atthe bridge 915 or earpieces 912 may instead have the electronics similarto those described above relative to housing 110.

In some examples, the treatment patch 924 may be disposable and may beremovably connected to the frame 910 with a snap fit, for example with asnap element 923 on the treatment patch 924 including a channel 927configured for receiving a tubular portion 913 of the lateral frameextension 917, as shown in FIG. 9B. Instead of traditional glasses typeframes that are held off the face, the frame 910 may follow the contoursof the face in order to hold the treatment patches 924 against the skinunder the eyes.

In some examples, the entire treatment patch 924 may define an electrode922. In other examples, a smaller electrode may be disposed on thesurface of or embedded within the treatment patch 924. The treatmentpatch 924 and electrode 922 may be similar in material and configurationto treatment patch 824 and electrode 822 a, 822 b discussed above. Instill further examples, the treatment patch 924 may be eliminated andthe tubular portion 913 of the lateral frame extension 917 may includethe electrode 922. The tubular portion 913 may be covered with a gelpad. The electrode 922 may be a used in a monopolar fashion, and thewearable device 900 may further include a return electrode 918 coupledto the earpiece 912. In one example, the return electrode 918 may beprovided as a contact point on the earpiece 912, and located to contactthe patient behind the ear, as shown in FIG. 9B. In some embodiments,two return electrodes 918 may be provided, one on either earpiece 912.In other examples, the return electrode 918 may be placed on any portionof the patient's body spaced apart from the eye area, including thetemples, mouth, neck, back, shoulder, chest, back of the hand, arm, etc.Electrode 922 may also be used in a bipolar fashion by providing morethan one electrical contact, such as by having two electrodes 922 thatcan be separately addressed (that is, separately used as anode andcathode, or as output and ground, or as current source and currentsink).

In some examples, the controller 940 may communicate with a physician'sunit 942 to receive programming information. The physician's unit 942may monitor the treatment patch 924. The controller 940 may be wireless,operating on a cellular signal, Bluetooth, or other wireless controlsignal to receive and transmit information to the physician's unit 942.

A further wearable device 1000 for providing therapy is shown in FIGS.10A and 10B. The wearable device 1000 may include a frame 1010configured to be worn on the bridge of the patient's nose similar to apince-nez. The frame 1010 may include nose grips 1011. First and secondtreatment pads 1020 a, 1020 b are coupled to the frame 1010 and areconfigured to provide therapy to the patient's eyes. In some examples,the first and second treatment pads 1020 a, 1020 b are integrated intothe frame 1010 such that the frame 1010 and treatment pads 1020 a, 1020b are a monolithic, single piece structure. The treatment pads 1020 a,1020 b may each include a treatment patch 1024 disposed on the undersideconfigured to contact the closed eyelids. In some examples, thetreatment patches 1024 may be padded or may be gel pads, and may beremovable and disposable or fixedly attached and reusable. Eachtreatment pad 1020 a, 1020 b may include an electrode 1022 disposedunder the treatment patch 1024, configured to provide therapy to theeye. In some examples, the electrodes 1022 may be adapted for bipolartherapy by providing a compound electrode with two or more separatelyaddressable contacts in close proximity to one another beneath atreatment pad and/or on the same eye, for example located superior andinferior or medial and lateral around the eye. In other examples, theelectrodes 1022 may be used in a monopolar fashion and the frame 1010may include one or more return electrode (not shown) configured tocontact the temples, similar to the return electrodes 818 shown in FIG.8A. In other examples, one or more return electrode may be placed on anyportion of the patient's body spaced apart from the eye area, includingon or behind the ear, mouth, neck, back, shoulder, chest, back of thehand, arm, etc.

As illustrated in FIGS. 10A-10B, the treatment pads 1020 may be shapedto match the patient's eye socket. The outer perimeter of the treatmentpads may include a soft material, such as a foam, to interact with thetissue surrounding the eye to enhance comfort. In some examples theouter perimeter may have a soft but resilient shape that aids inretaining the treatment pads 1020 in the eye socket, with therapyelectrodes thereof against the patient's skin, below or above the eyeand/or on the upper or lower eyelid, for example. Treatment pads 1020may be provided in an array of sizes and/or shapes, or may be custommade or custom fitted for individual patients. For example, a centralportion of the treatment pads may house electronics and a power sourcesuch as a battery, with a replaceable or custom-shapeable perimeterpiece thereabout.

Each treatment pad 1020 may include a battery 1016, as shown in FIG.10B, as well as electronics similar to those described above relative tohousing 110. The batteries 1016 may be disposed on trays 1019 that slideinto and out of the treatment pads 1020. In some examples, the batteriesare replaceable and may be disposable or rechargeable. For rechargeablebatteries 1016, the wearable device may further include a charging unit1026 configured to receive the treatment pads 1020 as shown in FIG. 10B.The charging unit 1026 may have a wired plug 1030. In another example,one treatment pad 1020 carries the battery, whether rechargeable or not,while the other treatment pad 1020 carries the electronics.

A controller 1040 such as an app on a mobile phone, tablet, or computermay be provided for operating, programming and monitoring the treatmentpads 1020. The wearable device 1000 may have a wireless connection tothe controller 1040 such as a cellular signal, Bluetooth, or otherwireless control signal.

A further wearable device 1100 for providing therapy is shown in FIGS.11A and 11B. The wearable device 1100 may include a frame 1110configured to be worn on the patient's face like eyeglasses. The frame1110 may include two earpieces 1112 configured to extend along the sidesof the face and over the ears, and a front piece or bridge 1115extending between the earpieces 1112 and over the bridge of the nose. Insome embodiments, the frame 1110 may include a plurality of prongs 1125extending from the frame 1110, as shown in FIG. 11A. In some examples,at least some of the plurality of prongs 1125 are hinged and movebetween a first, contracted position in which the prongs 1125 aredirected away from the users face, and a second, expanded position inwhich the prongs 1125 extend at an angle from the frame 1110 and intocontact with the skin. FIG. 11B shows the prongs 1125 in the second,expanded position. In the first, contracted position, the prongs 1125would be hidden behind the earpiece 1112.

As shown in FIG. 11B, each prong 1125 may have a contact point 1124configured to contact skin of the patient's face when the frame 1110 isin position on the face. Each contact point 1124 may include anelectrode 1122 configured to provide therapy to the patient.

The frame also includes a nosepiece shown generally at 1130, having nosegrips 1132, on which are mounted electrodes 1134. The nose grips 1132may be adjustable, similar to standard eyeglass fittings; rather thantwo separate prong-shaped nose grips, a V-shaped piece may instead beused in other examples, with one or more electrodes placed on theskin-facing surface of the V-shaped piece. The nosepiece electrodes 1134may be used relative to the electrodes at 1122, for example, orelectrodes carried on the earpieces 1112, such as, for example andwithout limitation, with earpiece electrodes 1404 or 1504 as shown inFIG. 14A and FIG. 15A, respectively. For example, therapy delivery mayuse the left or right nosepiece electrode (or the two ganged together)relative to one or the other of the right and/or left earpieceelectrodes, as well as combinations, sequences or patterns thereof.

In some examples, the electrodes 1122 may be used in a bipolar fashionby having two separately addressable electrodes 1122 on an eyepiece. Inother examples, the electrodes 1122 may be used in a monopolar fashionand the frame 1110 may include one or more return electrode (not shown)configured to contact the temples, similar to the return electrodes 818shown in FIG. 8A. In other examples, one or more return electrode may beplaced on any portion of the patient's body spaced apart from the eyearea, including on or behind the ear, mouth, neck, back, shoulder,chest, back of the hand, arm, etc. The electrodes 1122 and/or 1134 maybe, if desired, wet electrodes having a wettable polymer or naturalfiber, such as a cellulose (for example, similar to Weck-Cel® products)that may be pre-wetted to provide lower impedance tissue-electrodeinterfaces, or these electrodes may otherwise be any suitable polymer ormetal.

The frame 1110 may contain electronics similar to those described aboverelative to housing 110. The frame 1110 may include at least one battery1126, as shown in FIG. 11B. The batteries 1126 may be disposed withinrecesses in the earpiece 1112. In some examples, the batteries 1126 arereplaceable and may be disposable or rechargeable. For rechargeablebatteries 1126, the frame 1110 may have a charging port 1116.

Similar to the wearable device 1000, the wearable device 1100 may beused with a controller 1040 (shown in FIG. 10B) such as an app on amobile phone, tablet, or computer, that may be provided for operating,programming and monitoring the electrodes 1122. The wearable device 1100may have a wireless connection to the controller 1040 such as a cellularsignal, Bluetooth, or other wireless control signal.

FIGS. 12 and 13 illustrate further examples of wearable devices 1200,1300 for providing therapy to a patient. The wearable device 1200 shownin FIG. 12 may include first and second treatment patches 1224 and aconnector 1230 connectable to a controller 1240 containing circuitryelectrically connected to the treatment patch 1224. The treatmentpatches 1224 may be connected by a bridge portion 1225 configured to beplaced over the bridge of the nose. The treatment patches 1224 may beconfigured to extend over each eye. The treatment patches 1224 may havean adhesive backing configured to adhere the treatment patches 1224 tothe skin around the eyes. In some examples, the adhesive may berepositionable and reusable. In other examples, removable double-sidedadhesive pads may be provided to adhere the treatment patches 1224 tothe face.

The treatment patches 1224 may include one or more electrodes 1222. Insome examples, the entire treatment patch 1224 defines the electrode1222. In other examples, the electrode 1222 may be disposed on the lowersurface of the treatment patch 1224 or may be disposed within layersforming the treatment patch 1224. The treatment patches 1224 andelectrode 1222 may be similar in material and configuration to treatmentpatch 824 and electrode 822 a, 822 b discussed above. In some examples,one or more return electrode (not shown) may be provided on the wearabledevice 1200 or as a separate element electrically coupled to the device1200. The return electrodes may be placed on any portion of thepatient's body spaced apart from the eye area, including on or behindthe ear, on the temple, on or near the mouth, neck, back, shoulder,chest, back of the hand, arm, etc.

The controller 1240 may contain electronics similar to those describedabove relative to housing 110. The controller 1240 may be configured tocontrol electrical therapy delivery by the electrode 1222. In someexamples, the controller 1240 may include a wall plug. In otherexamples, the controller 1240 includes a battery, either a disposablebattery or a rechargeable battery and a charging port 1216. Thecontroller 1240 may have a touch pad or a plurality of buttons 1241configured to allow the patient to turn the treatment patch 1224 on andoff. In some examples, the controller 1240 may include wirelessconnectivity to a patient's or physician's cellular phone or tablet (notshown). The connectivity may be through a cellular signal, Bluetooth, orother wireless signal. The wearable device 1200 may be particularlyadvantageous for treatment with the eyelids open, which may provide foran improved and more convenient experience for the patient. In someexamples, the treatment patch 1224 may include padded, foam, or gelregions. For example, the entire treatment patch 1224 may be formed of afoam, padded strip, or gel frame, to provide additional comfort to thepatient. The treatment patch 1224 may be formed from a flexible materialsuch as fabric or polymer that is malleable and moldable to the contoursof the face.

The wearable device 1300 shown in FIG. 13 may include a treatment patch1324 and a connector 1330 connectable to a controller 1340 containingcircuitry electrically connected to the treatment patch 1324. Thetreatment patch 1324 may have an adhesive backing configured to adherethe treatment patch 1324 to the skin around the eyes. In some examples,the adhesive is repositionable and reusable. In other examples,removable double sided adhesive pads may be provided to adhere thetreatment patch 1324 to the face. In still further examples, thetreatment patch 1324 is disposable and removable from the connector1330. The treatment patch 1324 may be placed under the eye, asillustrated in FIG. 13 . In other examples, a treatment patch 1324 a maybe placed over the eye.

The treatment patch 1324 may include one or more electrodes 1322. Insome examples, the entire treatment patch 1324 may define the electrode1322. The electrode 1322 may be disposed on the bottom surface of thetreatment patch 1324 or may be disposed within layers forming thetreatment patch 1324. The treatment patch 1324 and electrode 1322 may besimilar in material and configuration to treatment patch 824 andelectrode 822 a, 822 b discussed above. In some examples, the electrode1322 may be used in a monopolar fashion with a return electrode 1318disposed on the connector 1330 and configured to be in contact with anyportion of the patient's body spaced apart from the eye area, includingthe temple, on or behind the ear, mouth neck, back, shoulder, chest,back of the hand, arm, etc., as described above for return electrode 418in FIG. 4 .

The controller 1340 may contain electronics similar to those describedabove relative to housing 110. The controller 1340 may be configured tocontrol electrical therapy delivery by the electrode 1322. In someexamples, the controller 1340 may include a wall plug. In otherexamples, the controller 1340 includes a battery, either a disposablebattery or a rechargeable battery and a charging port. The controller1340 may have a touch pad or a plurality of buttons configured to allowthe patient to turn the system on and off. Additionally the controller1340 may allow the patient to activate and deactivate the electrode1322. In some examples, the controller 1340 may include wirelessconnectivity to a patient's or physician's cellular phone or tablet (notshown). The connectivity may be through a cellular signal, Bluetooth, orother wireless signal. The wearable device 1300 may be used to treat theeyes while open, which may provide for an improved and more convenientexperience for the patient. In some examples, the treatment patch 1324may include padded, foam, or gel regions. For example, the entiretreatment patch 1324 may be formed of a foam, padded strip, or gelframe, to provide additional comfort to the patient. The treatment patch1324 may be formed from a flexible material such as fabric or polymerthat is malleable and moldable to the contours of the face.

FIGS. 14A-14F illustrate another illustrative medical device. In thisexample, a wearable device 1400 is generally in the form of a framehaving an earpiece 1406 and a nosepiece 1410 to be held on the head of auser. The frame carries one or more front electrodes or electrode pads,referred to as electrodes 1402, which are shown adapted for contact withthe upper eyelid of the patient/user. In another example, the electrode1402 may instead by positioned to contact the tissue overlying the nasalbone of the patient/user. In another embodiment, electrodes 1402 can bepositioned to contact the forehead of the patient. The electrodes 1402are carried on an electrode carrier 1402A, which can be adjustable suchas with a folding scaffold, foam, wire, or spring-loaded carrier toallow adjustment of the position thereof relative to the patient's uppereyelid or forehead, depending on the desired position.

The earpiece 1406 may include an electrode 1404; such an electrode 1404may be provided on either or both earpieces. A battery may be held inthe earpiece 1406, as indicated by the battery cover shown at 1408. Asshown by the top view in FIG. 14B, as well as in 14A, a chamber orisland for holding and/or receiving electronics of the wearable device1400 may be included at 1414 and 1416. If desired, a port 1412 may beprovide to receive a USB, micro-USB, or other input.

The nosepiece 1410 may include one or more electrodes for placement onthe nose of the user/patient as well, similar to that discussed aboverelative to FIGS. 11A-11B.

In some examples, a case—similar to a glasses case—may be provided tothe user along with the wearable device 1400. Such a case may include aninductive element or antenna and associated driving circuitry configuredto provide wireless power to a corresponding receiver circuit (such asan inductive coil or an antenna) in the wearable device, allowing powertransfer that can be used to recharge a battery in the wearable device.A charging case structure is disclosed as well in U.S. patentapplication Ser. No. 16/844,421, filed on Apr. 9, 2020, and titledSYSTEMS AND INTERFACES FOR OCULAR THERAPY, the disclosure of which isincorporated herein by reference.

FIG. 14C illustrates details of a removeable form of the electrode 1402.The electrode 1402 may include a gel region 1420 which may bereplaceable, or the electrode 1402 may be replaceable in its entirety.For holding the replaceable electrode 1402 in place relative to thewearable device 1400, there may be one or more magnets 1422. Fordelivery of current, an electrical contact 1424 may be included. Theframe 1400 may comprise a receiver shaped to match the design shown inFIG. 14C; the shape, contours, and quantity of magnets and electrodes ismerely illustrative. An adhesive or snap fitting may be used instead ofmagnets, if desired.

An upper or lower eyelid electrode may have a size in the range of about1 to about 40 mm in length, and about 1 to about 10 mm in width, orgreater or lesser in either dimension. As used here, length refers tothe dimension lateral to midline when the electrode is applied, andwidth is the dimension parallel to midline of the patient. In someexamples the length of an upper or lower eyelid electrode may be about10 to about 20 mm and width about 2 to about 5 mm. The area of suchelectrodes may be in the range of about 1 to about 400 squaremillimeters, or about 10 to about 200 square millimeters, or larger orsmaller. A compound electrode may be, for example, a set of 2 to 4 roundelectrodes each having an area of 10 to 15 square millimeters, combiningto provide about 20 to about 60 square millimeters, though larger orsmaller sizes and quantities may be used instead.

A forehead electrode may have a size in the range of about 1 to about 80mm in length, and about 1 to about 30 mm in width, or greater or lesserin either dimension. In some examples the length of a forehead electrodemay be about 15 to about 40 mm, and the width may be about 10 to about20 mm.

A nose piece electrode may have a size in the range of about 1 to about20 mm in length, and about 1 to about 20 mm in width, or greater orlesser in either dimension. In some examples the length of a nose pieceelectrode may be about 4 to about 8 mm in width and about 8 to about 15mm in length. One or more electrodes on a nose piece may include, forexample and without limitation, a single electrode medially placed, orplaced to extend on both sides of midline, or may include two or moreelectrodes including at least one each on the right side and left sideof the upper portion of the nose.

Electrode contact surfaces may have any suitable shape including square,rectangular, oval, circular, etc., without limitation. Electrode edgesmay be beveled or rounded to enhance comfort and avoid potential edgeeffects with therapy delivery (in which current density is increased atthe edges of an electrode-tissue interface). A compound electrode may beused, with multiple individual segments that may move together or whichmay be provided on separate support apparatuses (wires, spring, foam,etc.), or a single electrode. Longer electrodes may be curved toaccommodate anatomical curvature of the upper or lower eyelid/eyeball,and or the check or forehead, as the case may be. A concave curvaturemay be used on the forehead or an eyelid to match to the anatomy in someexamples. In other examples, a convex curvature may be used to ensuresolid contact across a portion of an electrode. Still other examples mayuse flat electrodes. In some examples, electrodes for any location(forehead, upper eyelid or lower eyelid) may come in a range of sizes,shapes and/or curvatures, or may be custom built for each patient.

Generally speaking, larger electrodes may be more suitable for use onthe forehead than electrodes used on the eyelid, though the overallranges may remain within the above ranges, more or less. When designingelectrodes, various benefits and disadvantages can be considered. Forexample, a large, flat electrode offers easy manufacture and large area,but may not provide good contact when placed on the skin of a user,which is typically neither flat nor smooth around the eyes. Smaller,button-type electrodes may provide secure contact, but less surfacearea. Compliant electrodes may be more difficult or more expensive tomake, and possibly less durable than rigid options, but may combinegreater surface area with better contact. The skin-tissue interface hasan impedance that is proportional to the contact area between theelectrode and the tissue, among other factors, so smaller surface areamay tend to raise impedance. A dry electrode may have a greaterimpedance in general than a wettable electrode or a gel electrode, butmay have longer useful life and greater durability. Multiple smallerelectrodes may be provided in a compound electrode and may be used,electrically, separately from one another or as a common pole for theoutput of current or voltage, and a compound electrode carrier/substratemay be flexible to provide optimal contact for each of the multipleelectrodes. The consideration of these factors in selecting anddesigning electrodes is within the scope of the present invention.

In any embodiment throughout the disclosure dry electrodes may provideadvantages. Examples of dry electrodes are discussed, for example, in“Development of printed and flexible dry ECG electrodes”, Chlaihawi, AA, etc. Sensing and Bio-Sensing Research, 20 (2018), 9-15. It may be insome examples that a simple metal electrode, such as a silver, medicalgrade stainless steel, gold or other metal electrode can be used.

FIG. 14D shows the front side of one design for an electrode, such asthe eyelid-located, or alternatively, forehead located, electrode ofFIG. 14A. In this example, a conductive gel surface 1420 is placed overan electrode conductor 1426, which is shown in phantom for illustrativepurposes. In an alternative, a dry electrode or electrodes may be used.The electrode conductor 1426 may provide structure to support the gelsurface 1420. In other examples, multiple electrodes may be provided onone compound electrode.

FIG. 14E shows a compound electrode 1430, having first and secondelectrodes 1432, 1434 thereon. In this example, as shown in FIG. 14F,which is a side view of the electrode shown in a frontal view in FIG.14E, it can be seen that the first and second electrodes 1432, 1434extend away from the surface defined by the body of the compoundelectrode 1430, which may aid in obtaining good contact against theuser's skin. The first and second electrodes 1432, 1434 may be dryelectrodes, wettable electrodes, or may have gel pads, eitherindividually or across the whole surface of the compound electrode 1430.

For purposes herein, an electrode assembly may be either a singleelectrode or a compound electrode having two or more individuallyaddressable electrodes thereon. Any of the examples herein that show asingle electrode should be understood as also disclosing the use of acompound electrode, rather than a single electrode, having two or moreindividually addressable electrodes thereon. The back side of thecompound electrode 1430 is shown in the side view of FIG. 14F as well,and includes a coupling protrusion 1436 extending therefrom, sized andshaped to be received in a corresponding slot or port of a wearabledevice.

In some examples, and in particular in each example showing a frame-typewearable instrument (such as FIGS. 11A-B, 14A-B, 15A-B, 16 and 17A), oneor more electrodes may be part of a spring-loaded assembly that willapply pressure between the wearable device and the electrode tofacilitate contact with the patient's skin. For example, a spring loadedaccordion structure, or a foam or sponge piece, one or more miniatureleaf springs (an arc-shaped spring structure) may be used as anelectrode carrier (FIG. 14B, at 1402A, FIG. 15B, at 1502A) or in as acoupling protrusion (FIG. 14F, at 1436). In some examples, theelectrodes may be provided on a pivoting or swivel structure to aid inobtaining good contact, for example, nose grips (FIG. 10A/B, at 1011,FIG. 11B at 1132), or prongs (FIG. 11A, at 1125) may be coupled to aframe with a pivot or a swivel. The electrodes may come in a range ofsizes and/or shapes, and support structures to hold the electrodes inplace may be adjustable or may come in a range of sizes to allow aphysician to tailor the device to a particular patient's anatomy,similar to how an optometrist can fit glasses to a user. In someexamples, the overall frame may come in a range of sizes, or may bedesigned with replaceable portions, such as for contacting the bridge ofthe nose or the ears, or the arm extending from the ear, to adjust forindividual patient anatomy.

FIGS. 15A-15B show another illustrative medical device. In this example,the wearable device 1500 is generally in the form of a frame having anearpiece 1504 and a nosepiece 1510. The frame carries one or more frontelectrodes or electrode pads, referred to as electrodes 1502. Theelectrodes 1502 are carried on an electrode carrier 1502A, which can beadjustable such as with a folding scaffold, foam, wire, or spring-loadedcarrier to allow adjustment of the position thereof relative to thepatient's upper eyelid or forehead, depending on the desired position.The earpieces 1504 may include an electrode 1506, and one (or both, ifdesired) earpiece 1504 may include an attached or removeable wire 1508that may be used to couple to a return electrode placed elsewhere on theuser (such as on the torso, neck, limb, wrist, or hand). Alternatively,the wire 1508 may couple to a pulse generator or a charger, which mayalso have a return electrode thereon, and which may also house circuitryand/or a power supply for the delivery of therapy.

In some examples (including at least that of FIGS. 15A-15B, but alsoothers having a remote electrode tethered via a wire to a frame), theframe may carry electronics for generating therapy signals, and a remoteelectrode can be carried on a housing that holds replaceable orrechargeable batteries. Such a configuration of a remote electrode on ahousing carrying a power source may be used in any other exampledisclosed herein as having a remote electrode, providing the benefit ofreduced weight on the frame itself and facilitating use of heavierbatteries (or relatively cheap, standard size batteries, such as AA, AAAor 9V batteries) that would not require frequent recharging orreplacement.

In this example, the nosepiece 1510 is somewhat larger and may include aslot or chamber for receiving a battery cell or cells, or a batterypack, such as one or more button batteries. The battery may be aprimary, non-rechargeable cell, or may be rechargeable, if desired. Thenosepiece 1510 may also carry electronics for the therapy device aswell, if desired. As shown as well in the top view of FIG. 15B, regions1512, 1514 may be enlarged to receive electronics for the device 1500.The nosepiece 1510 may include one or more electrodes for placement onthe nose of the user/patient as well, similar to that discussed aboverelative to FIGS. 11A-11B.

FIG. 16 shows another illustrative medical device. In this example, atreatment device 1600 is configured to be placed over/on a glasses frame1630, as indicated by arrow 1620. The treatment device 1600 may be madeof a flexible polymer to receive the glasses frame 1630 in a slot 1614that can be formed along the nosepiece 1610 and may also extend alongregion 1616 and, optionally, region 1618, as well as in or near theearpieces 1604.

The treatment device 1600 is shown carrying electrodes 1602 (again, inan example, suitable for placement on the upper eyelid or,alternatively, on the forehead) and including earpieces 1604, which mayeach carry an electrode 1606. One or more of the earpieces 1604 mayinclude a wire 1608 for coupling to a remote return electrode or a pulsegenerator or charger, as desired. Again, the treatment device 1600 mayinclude enlarged regions 1612 for housing or receiving electronicstherein. If desired, the nosepiece 1610 may be adapted to receive orhouse one or more battery cells or a battery pack. As used herein, abattery pack may comprise a frame that receives one or more batterycells in a customized manner to make for easy placement and removal froma wearable medical device. The nosepiece 1610 may include one or moreelectrodes for placement on the nose of the user/patient as well,similar to that discussed above relative to FIGS. 11A-11B.

FIGS. 17A-17D show another illustrative medical device. The example heretakes the form of a wearable device 1700 generally in the form of aframe, similar to an eyeglasses frame and adapted to receive lenses1720, which may be prescription lenses that correct vision, if desired.As generally shown, a front piece having a nose piece 1714 and carryingan electrode or electrode pad 1702 is coupled to first and second armsthat extend to earpieces 1706 that are shaped to contact and rest, atleast partly, on the ear(s) of the user; the earpieces 1706 may, in someexamples, at least partly wrap around the ear of the user. The lensesmay be placed as shown at 1722 in a slot 1716 configured to receive themin a friction fit or snap fit fashion, for example. The lenses may also,or instead, provide light protection, for example, making the wearabledevice 1700 suitable for use as sunglasses. Lenses 1720 may be omittedin other examples.

As shown in FIG. 17A, the wearable device 1700 includes electrode pads1702, adapted for placement on the upper eyelid or, alternatively, onthe forehead. The electrode pads 1702 may comprise one, two, or moreaddressable electrical contacts (which may be separately addressableand/or ganged together for output or sensing purposes), and may bepermanently fixed, disposable, or may include electrical contactssurrounded or covered by a replaceable element such as a gel pad, awettable element (such as a cotton pad), or may simply be electrodeswithout added layers/padding. The electrode pads 1702 may be adjustable,either or both of in terms of the shape of the pad (to match the user'sforehead) and in terms of how each is juxtaposed relative to the overalldevice 1700 (to accommodate different face sizes and shapes). Electricalwiring (not shown) can run through the eyeglasses-type frame shown fromthe power supply to the electronics and electrodes, wherever each ispositioned; the electrical wiring may be selected to be of relativelylarger gauge to provide structural support and/or adjustability, ifdesired, or may be lightweight with separate metal structures providedfor structural support and/or adjustability. The nosepiece 1714 includeone or more electrodes for placement on the nose of the user/patient aswell, similar to that discussed above relative to FIGS. 11A-11B.

In another example, the earpieces 1706 may be replaceable/swappable,while the remainder of the frame shown is custom to a given patient,such as by using 3D printing or other tailored manufacturing process forthe rest of the device 1700, allowing the use of modular, pre-programmedor powered earpieces (assuming the electronics and/or power source arecarried there). For example, rather than having a user with impairedeyesight attempt to swap out small batteries (similar in size to thoseused in hearing aids for example), the user could change out an entireearpiece, which may be easier to do. In some examples, the device 1700may have only one electrode pad 1702, such as for a user needingtreatment on only one eye. The shape of each earpiece and the armextending thereto may be customizable, using methods, materials anddesigns known for eyeglasses.

Earpieces 1706 may carry electrodes 1704 that are held by flexible, oradjustable/shapeable, arms 1708. One or both earpieces 1706 may includea switch 1710 for turning the device on/off, as well as indicator lightsthat may be used to display status (on/off/error, for example). Expandedregions 1712 are optionally provided on the device 1700 and may receiveor hold electronics. A nosepiece 1714 is again provided, and may besized/shaped to hold or receive a power supply, such as one or morebatteries or a battery pack for the system, with the batteries beingeither rechargeable or non-rechargeable.

In other examples, the earpieces may house the power supply andelectronics. For example, earpiece 1706 is shown in the foreground ofthe Figure; a second earpiece is obscured from view by lens 1720.Earpiece 1706 may have the switch 1710 and electronics for the system,with a rechargeable or non-rechargeable (permanent or replaceable)battery carried in the obscured earpiece, which may serve an advantageby reducing the weight of the device 1700 carried on the nose of theuser. As noted, power supply and electronics may be placed at 1712/1714,which would put more weight on the user's nose, potentially providing amore secure placement of the electrode pad 1702. Other arrangements ofthe power source/battery and electronics may be used instead.

One or both earpieces may include an inductive recharging circuit (inthe case of a device having a rechargeable battery), though suchinductive recharging circuit may also be elsewhere such as in theoptional expanded regions 1712 and/or nosepiece 1714, for example.Additionally, or alternatively, a port may be provided on any of theearpiece 1706 or front portion or nose piece of the device to receive awire plug, such as a micro-USB plug, to facilitate recharging of abattery and/or reprogramming of a therapy output circuit. In someexamples, a wireless communication circuit may be provided, such as aBluetooth or Bluetooth Low Energy circuit, to allow telemetry with aprogramming device such as a clinician programmer or patient controller,either of which may be a dedicated device or may be a general purposedevice (such as a smartphone or tablet computer) having a specificsoftware application thereon usable for programming purposes.

FIGS. 17B-17D show alternative earpiece configurations. As shown in FIG.17B, the earpiece 1730 may couple to an electrode at an edge thereof,with a first pivot at 1734 in the form of a ball joint allowing movementof the electrode 1732 to match the contour of the patient's skin. Asecond pivot is provided at 1736, allowing motion within a rangeillustrated at 1738. The combination of pivots 1734, 1736 may aid incomfortable and secure positioning of the electrode 1732.

FIG. 17C shows another example. Here, the earpiece 1750 includes anelectrode 1752 that can be snapped into a slot for receiving it andcoupled to the earpiece 1750 by a wire/tether 1754. In this example, theelectrode 1752 may be a replaceable element and/or may have areplaceable sticky interface thereon. Thus the electrode 1752 can becarried on the earpiece 1750 when not in use, and removed from its slotfor use.

FIG. 17D shows another alternative earpiece. Here, the earpiece 1770 iscoupled to an electrode 1772 with a ball joint 1774, which can be usedto orient the electrode 1774 relative to the contour of the patient'sskin, achieving good and comfortable contact across the area of theelectrode 1774. A second pivot is provided at 1776, allowing motionwithin a range shown by arrows 1778.

Several examples herein, including that shown in FIGS. 1 , some versionsof FIGS. 11A-11B, FIGS. 12, 14A-14F, 15A-15B, 16, and 17A-17D, may becharacterized by the omission of any electrode on the face of the userbelow the palpebral aperture. Certain prior attempts at electricaltherapy delivered to the eye may include electrodes disposed around theeye, superior as well as inferior to the palpebral aperture, however,such therapy delivery may focus energy toward the anterior of the eye,rather than directing current deeper into the eye where the maculaeand/or optic nerve can receive delivered energy. Thus, and for example,earlier or alternative devices that use anterior-placed electricalstimulus to provide therapy to eye and/or surrounding tissues may bedifferentiated in these example embodiments. Other examples, as shownabove, may include electrodes about the eye opening.

The following description applies to any of the above described wearabledevice 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200,1300, 1400, 1500, 1600, and/or 1700, but for simplicity, the referencenumbers for wearable device 100 will be used. The treatment patches 124may be disposable or reusable. The reusable treatment patches 124 may bepermanently attached to the wearable device 100. The controller 140 mayprovide control of the pattern of electrode 122 activation as well as anon/off switch, or just provide an on/off switch. The wearable device 100may utilize rechargeable batteries, disposable batteries, or a powercord. The rechargeable batteries may be charged using a USB chargingcord or an induction unit. Any of the treatment patches 124 discussedabove in any embodiment may be dry or wet. Therapy may be delivered inbipolar fashion (such as using first and second electrodes both disposedabout a single eye of the user) or monopolar fashion (such as using afirst electrode on the eye of the user and a second, return electrodedistant from the eye. The return electrode for any embodiment discussedabove may be placed on any portion of the patient's body spaced apartfrom the eye area, including on or behind the ear, on the temple, on ornear the mouth, neck, shoulder, back, chest, back of the hand, arm, etc.

In some embodiments, the wearable device 100, 200, 300, 400, 500, 600,700, 800, 900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, and/or 1700(and variations, systems or components thereof disclosed herein) and/orportions thereof, may be made from or include plastics, metals, alloys,fabrics, composites, or combinations thereof. As variously stated above,the wearable devices 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000,1100, 1200, 1300, 1400, 1500, 1600, and/or 1700 may carry or contain, orbe connected, such as by a wired connection, to electronics as describedabove relative to housing 110 including, for example, a microcontroller,memory, sensing input circuitry, and output circuitry for generating anysuitable form of output, including voltage, current, light, mechanicalenergy, etc.

The above examples may be used for delivering ocular modulation therapy.As used herein, “ocular modulation” refers to the treatment of the eyewith a signal, delivered non-invasively, or minimally-invasively, toachieve a therapeutic benefit. Therapeutic benefit may include, forexample and without limitation, improving or altering blood flow,upregulating or downregulating synthesis, degradation, binding, releaseor activity of proteins, enzymes, DNA, RNA, polysaccharides or otherendogenous physiological or pathological biomolecules; and/orupregulating, downregulating, activating, deactivating physiological orpathological biopathways, etc. Ocular modulation may be combined withthe administration of pharmaceuticals, exogenously derived biomolecules,cell therapy, or photo-, electro- or magneto-reactive or activeparticles, such as nanoparticles, before, during or after an electricalsignal is applied.

In some examples, the devices and systems disclosed herein are suitedfor use in conjunction with exogenous and/or endogenous stem celltransplantation therapies. For example, a method may comprise deliveryof electrical stimulation before, during, or after stem celltransplantation to improve cell survival, integration, repair and/orreplacement. In some illustrations, the use of methods and systemsdisclosed herein may enhance native cell survival, transplanted cellsurvival, transplanted cell integration, and functional synapseformation and/or axon regeneration. For example, a transplanted orimplanted cell scaffold be encouraged to successfully integrate with theretina by the application of electrical fields, including by the use ofstatic or varying fields, wherein variation may include any of spatialor temporal variation. Non-limiting examples of endogenous stem celltypes which may be suitable for transplantation in combination withsystems or devices of the present invention include Müller cells,retinal pigment epithelial cells (RPE cells) and ciliary pigmentedepithelial cells (CPE). Non-limiting examples of exogenous stem cellssuitable for transplantation according to some embodiments of theinvention include neural stem cells (NSCs), mesenchymal stem cells(MSCs) derived from bone marrow, adipose tissue or dental pulp and stemcells from the inner cell mass of the blastocyst and induced pluripotentstem cells (iPSCs). See, for example, “Using Electrical Stimulation toEnhance the Efficacy of Cell Transplantation Therapies forNeurodegenerative Retinal Diseases: Concepts, Challenges, and FuturePerspectives”, Abby Leigh Manthey, et al., Cell Transplantation, Vol.26, pp. 949-965, 2017.

In some examples, combination of therapy systems of the invention withbiological or pharmaceutical agents may provide improved efficacy orreduced side effects associated with such biological or pharmaceuticalagents when administered alone. Pharmaceutical agents currently used toreduce the growth of new blood vessels in wet AMD includeanti-angiogenics such Bevacizumab (Avastin®), Ranibizumab (Lucentis®)and Aflibercept (Eylea®), etc. While the benefit of these agents formitigating symptoms associated with wet AMD are known, these also mayhave side effects including increased eye pressure, inflammation of theeye and others. A benefit of systems disclosed herein includesmodulation of cytokines and other endogenous inflammatory factorsinvolved in the inflammation process. In some embodiments it is foreseenthat administration of anti-angiogenic agents or other pharmaceuticalsin combination with electrical therapy applied simultaneously with,before (e.g. 1, 2, 12, 24, 36, 48 and/or 96 or more hours before), orafter (e.g. 1, 2, 12, 24, 36, 48 and/or 96 or more hours after),injection of such anti-angiogenics, at stimulation parameters usedherein, may beneficially improve the efficacy and/or reduce thelikelihood of side effects associated with administration of suchagents.

Several different modes of energy delivery are disclosed, includingmechanical (such as sonic energy, including for example, ultrasound),light-based (such as by the delivery of collimated or non-collimatedlight using, for example, a laser, a light emitting diode, etc.),electrical (such as by the delivery of an electrical signal), and/ormagnetic (such as by generating a magnetic field or fields), andcombinations thereof. In some examples, one mode of therapy delivery isused, while the same or a different mode of sensing is used to monitortherapy delivery. One component of several examples is the use ofconfigurations that are adapted to provide enhanced tissue contact,enhanced therapy delivery location, improved efficiency of energydelivery, targeted therapy, reduced likelihood of tissue injury orirritation, and/or improved patient comfort and/or compliance.

In some examples, electrical stimulus may also be provided to facilitatediagnostics. For example, an electrical stimulus may be generated as acontrolled voltage, and current that flows may be measured, or voltagessensed at non-anode/cathode electrodes may be measured, to determineimpedances and/or tissue contact characteristics. Generally speaking,lower impedance indicates better skin contact and better energy orcurrent transfer characteristics.

Various features for delivering therapy may be understood by review of,for example and without intending limitation, U.S. Pat. No. 7,251,528 toHarold, U.S. Prov. Pat. App. No. 62/739,810, filed Oct. 1, 2018, titledSYSTEM AND METHODS FOR CONTROLLED ELECTRICAL MODULATION FOR VISIONTHERAPY, U.S. Prov. Pat. App. No. 62/774,093, filed on Nov. 30, 2018,titled HEAD WORN APPARATUSES FOR VISION THERAPY, and U.S. Prov. Pat.App. No. 62/832,134, titled SYSTEMS AND INTERFACES FOR OCULAR THERAPY,the disclosures of which are incorporated herein by reference as showingwaveforms, structures, apparatuses and systems for delivery of ocularmodulation. Such disclosures also provide additional options andimplementations of the electronics of the devices and systems herein.

In some examples, a bipolar electrode approach is taken, without the useof a remote return electrode. In other examples, a monopolar therapy canbe delivered, using one or more electrodes located on an eyelid or closeto the eye as anode or cathode, and a remote electrode elsewhere on theuser, such as on the head, torso or a limb. For example, a returnelectrode may be on the user's arm, hand, shoulder, chest, back, neck,mouth, on or behind the ear, or temple of the user. A biphasic therapymay be delivered, allowing for charge balancing of the output and makinguse of each electrode as both anode and cathode during therapy output.Alternatively, a monophasic therapy may be provided, making use ofparticular electrodes only as anodes or as cathodes; to avoidpost-therapy shock (similar to a static shock), the electrodes may begrounded for a period of time to drain any residual voltage on thetissue/electrode interface. In still further examples, both biphasic andmonophasic therapy are delivered, for example, in a patterned therapyusing each type of therapy delivery in alternating or cyclic fashion. Inan example, monophasic therapy may be provided for a fixed period oftime, with subsequent phase reversal and further delivery for anotherfixed period of time, avoiding over-polarization, which could lead to,for example, muscle recruitment or may encourage corrosion or otherdamage to the electrode-tissue interface.

Waveshape may vary. If desired, sinusoidal, triangular, ramped (up ordown), exponential (up or down), or square waves may be delivered in anyof current, voltage, or power controlled outputs. For example, a currentcontrolled output may provide a square wave of constant current for itsduration. In another example, a voltage controlled output may take theform of an exponentially decaying output. Other combinations and shapesmay be used if desired. In some examples, an output circuitry of theelectronics module may be configurable between a first configurationthat delivers current controlled outputs and a second configuration thatdelivers voltage controlled outputs. For example, a first feedback loopmay be provided that monitors voltage across the output electrodes (forvoltage control), while a second feedback loop monitors voltage across aresistor (for current control) that is in series with the outputelectrodes, and the controlling circuitry such as a microprocessor,ASIC, or state machine, can be programmed to select one or the other ofthe feedback loops to use.

In some examples, the output waveform may comprise a modulated carrierwave, such as a modulated 1 Hz to 1 MHz output, shaped as a square wave;higher or lower frequencies may be used. In an example, a carrier wavetakes the form of a square wave with a frequency of 1 kHz to 40 kHz and50% duty cycle, modulated by an envelope signal of a lower frequency asdiscussed in U.S. Pat. No. 7,251,528, the disclosure of which isincorporated herein by reference. The duty cycle may be anywhere from 1%to 100%, if desired. The envelope may be a square wave in the range ofabout 1 to about 100 kHz, more preferably about 1 to about 1000 Hz, orabout 1 to 400 Hz. In another example, the envelope may be at a selectedon of 10, 20, 30, 40, 50, 100, 200, 300, 500 or 1000 Hz; other envelopefrequencies may be used. In still another example, the user may receivea series of different frequency outputs, by varying the envelopefrequency and/or varying the carrier frequency. The carrier wave or theenvelope may be sinusoidal instead, if desired, or may have a differentshape such as triangular, ramped, etc. In some examples, additionalfactors may be programmable parameters, such as duty cycle, pulse widthof the carrier signal or envelope signal. In an example, a monopolaroutput is provided, with periodic changing of the polarity to maintaincharge balance at the tissue interface. For example, some embodiments ofa wearable therapy apparatus provide a stimulus output as a first trainof monophasic output pulses of a first polarity, and a second train ofmonophasic output pulses of polarity opposite the first train. In otherexamples, therapy output may be allowed to leave a residual chargeimbalance.

In another example, a therapy signal is provided with a frequency ofabout 1 Hz to about 1 MHz, and the combination of carrier and envelopeis omitted. For example an output may be provided as a biphasic squarewave with a frequency in the range of 10 Hz to 20 kHz, or about 100 Hzto about 15 kHz, with the output delivered for a fixed period of timesuch as 1 millisecond to about 1 hour, or about 100 milliseconds toabout 30 minutes. The waveform may be delivered repeatedly, at fixed orrandom intervals, and may take other shapes including triangular,sinusoid, etc. Therapy signals may be delivered with a soft turn-on orramp, in which the therapy output signal is ramped up from a startinglevel (such as 0 volts or 0 amps) up to the desired therapy level overthe course of a few milliseconds to a few seconds, or longer. Otherparameters including pulse width, off time, polarity switching frequency(if used), etc. may vary as well.

A programmable amplitude may be set using, for example, power, currentor voltage as the controlled variable. In some examples, current may bedelivered in the range of about 0.1 to 2000 microamperes, or in therange of about 1 to about 1000 microamperes, or in the range of about300 to 500 microamperes, using any of the above noted parameters forwaveshape, frequency, duty cycle, etc. Other specific settings may beused, including those disclosed and discussed in further detail in U.S.patent application Ser. Nos. 16/589,383, 16/697,689, and/or 16/844,421,U.S. Pat. No. 7,521,528, and/or U.S. Prov. Pat. App. 62/867,421,62/873,450, the disclosures of which are incorporated herein byreference.

The user may be allowed to freely modify parameters, or access may berestricted to a clinician user, or it may be that the user can modifyparameters within a narrower range controlled by a clinician. Forexample, a clinician may be enabled to set current in a range of 1 toabout 1000 microamperes, while the user can only modify the current,once set by the clinician, within a range of plus/minus 100microamperes, or more or less. In some examples, the user may not beallowed to change parameters. A method example may comprise the steps ofa user donning any of the preceding wearable devices, or alternativesthereto, to place the one or more electrodes thereof at a desired,instructed, or therapeutic position, and activating circuitry of thewearable devices, when so provided, to deliver therapy. Still anothermethod example comprises any of the preceding wearable devices issuingtherapy pulses via the electrodes thereof for purposes of treating,reversing, preventing, arresting, or otherwise addressing a disease ofthe eye or surrounding tissues.

In some examples, a closed loop approach may be taken wherein sensingcircuitry in the apparatus is configured to sense select parameters oftherapy delivery or sense other parameters, such as biological events.For example, it has been shown that users may experience flashes oflight, known as phosphenes, during therapy. To allow a user to performambulatory or other activities, phosphenes may be avoided by having thedevice sense for phosphenes and reduce power output when phosphenes aresensed to limit the impact to a user's visual experience. Anotherapproach may be to occasionally or periodically test a user's phosphenethreshold, such as at the start of a therapy session, and then settherapy parameters to use duty cycle, amplitude, current density, orother factor so therapy stimuli is delivered at a level that is belowthe phosphene threshold. Such testing may further include having a usermove his or her eye to different positions during threshold testing(i.e., looking up, down, left or right) by issuing one or more commandsto the user to modify eye position during phosphene threshold testing.Avoidance of phosphenes may also be useful for patients having otherconditions, such as epilepsy or migraines, which may be triggered orexacerbated by exposure to flashes of light.

The ability to select from various pairing of electrodes may be usefulto provide therapy targeting separate conditions by selective use of theelectrodes. For example, glaucoma is typically associated with fluidtransport structures in the eye that are more superficial, anatomically,than structures associated with a condition such as maculardegeneration. Therefore, in an example, relatively more closely spacedelectrodes, or bipolar therapy regimens, may be used to treat glaucoma,while more greatly spaced electrodes, and/or monopolar therapy regimensmay be used to treat macular degeneration, for a user having or at riskfor both conditions.

In a still further example, a current flowing between two electrodes onone eyepiece may be useful in glaucoma patients to cause contraction orexpansion of the ciliary muscle regions, opening the iris root andfacilitating drainage through the trabecular meshwork. In some examples,a current applied by an eyepiece may energize a stent placed in thetrabecular meshwork to aid fluid flow, or may energize a device placedelsewhere in the eye to cause other beneficial therapeutic effects suchas heating, light or electrical stimulus affecting neural or otherstructures in the eye. In examples it is envisioned the bipolarelectrode positioning around an eyepiece can provide selectedstimulation to rehabilitate an atrophied ciliary muscle before or afterimplantation of an artificial intraocular lens. In still other examples,other structures in the head may be targeted, such as the optic nerveand/or targets in or around the brain, the sinuses, or the eye.

Multiple therapy patterns or programs may be set for a device. Forexample, the electrical components may comprise a state machine ormicroprocessor with stored states or stored instructions, respectively,to deliver pre-selected therapy patterns or types. Therapy patterns maybe defined according to which electrodes are selected for use (and inwhich role—ground, anode, cathode, etc.), and output characteristics foreach output channel (pulse width, frequency, amplitude, relativeamplitude, pulse shape, duty cycle, inter-pulse intervals, burstpatterns, etc.). Such patterns or programs may be set by a physicianduring a programming session using, for example, a clinician device suchas a mobile phone, table or computer, or a dedicated programmer device,as desired.

While the above description generally shows the use of a battery orrechargeable battery, other power sources may be used. In some examples,a battery may be omitted and a capacitor or supercapacitor used instead,allowing charging and discharging over time. For example, a receivingantenna or inductive coil may receive energy output by a remote deviceand the received power can be used to charge a capacitor. Once thecapacitor is charged to a desired level, the capacitor can be dischargedto deliver therapy to the user. A determination that the capacitor is atthe desired level may be made by, for example, having a comparator inthe system to compare to a reference voltage, or by having asilicon-controlled rectifier that, once the desired voltage level isreached, will close a switch allowing discharge of the capacitor andopen again once the capacitor is discharged to at least a thresholdamount.

As noted, the control circuitry architecture may comprise amicrocontroller, microprocessor, or a state machine, as desired and assuitable to the particular needs of a system. Volatile or non-volatilememory may be included to store various parameters, settings and data,such as patient information, therapy programs that may be used, therapyparameter limits, diagnostic and/or usage history information, etc.Analog to digital conversion circuitry may be provided for convertingsensed signals, such as a sensed impedance, sensed phosphene, sensed eyemovement, output from an accelerometer, etc. to digital data foranalysis and/or storage. Digital to analog conversion circuitry may alsobe included to allow, for example, a control signal to be converted froma digital format to an analog output that controls one or more offrequency, waveshape, amplitude, etc. of an output stimulus or therapy.

While some examples the apparatus may sense when it is being worn by apatient, such as by sensing impedance between two electrodes, by sensinga thermistor output, or any other suitable sensing approach. In anexample, the user may turn the device “On” with a switch, but therapywill only initiate when the control circuitry determines that stimuluselectrodes have been placed on patient tissue with good contact (thatis, lower impedance) to avoid inadvertent shocking when the device isbeing adjusted, moved, donned, removed, etc.

In some examples, the electrical components used to deliver electricaltherapy via the electrodes may include a multi-channel topology.Separately addressable voltage and/or current sources may be used,having one source, two sources, or as many such sources as there areelectrodes, if desired, or even with more sources than electrodes. Somesources may output current (current sources) or drain current (currentsinks), while others may provide positive or negative voltages relativeto system ground/reference. In some examples, there may be dedicatedvoltage or current circuits for each electrode while in other examples,a bank of voltage or current generating circuits may be coupled by anarray of switches or a multiplexor to the output electrodes, allowingtherapy generating circuits to be ganged together on a single outputelectrode or spread out across a number of electrodes. A single channeloutput may be used instead, if desired.

Miniaturization of a neural stimulator has been taken to great lengthsincluding providing communication, pulse output, power storage and/orcontrol circuitry in implantable devices of just a few grams and cubiccentimeters, such as shown in U.S. Pat. Nos. 5,193,540 and 8,612,002,the disclosures of which are incorporated herein by reference. Moreover,the provision of multiple channel outputs has been shown as well,including for example in U.S. Pat. Nos. 5,643,330 and 6,516,227, thedisclosures of which are incorporated herein by reference. The circuitryand capabilities of the systems disclosed in these patents may beintegrated into a number of the above embodiments as desired.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of thedisclosure. This may include, to the extent that it is appropriate, theuse of any of the features of one example embodiment being used in otherembodiments. The claim's scope is, of course, defined in the language inwhich the appended claims are expressed.

What is claimed is:
 1. A system for providing electrical stimulation toa patient's eye comprising: a mask having a left opening for thepatient's left eye and a right opening for the patient's right eye, aplurality of electrodes including each of a left upper electrodepositioned above the left opening, a left lower electrode positionedbelow the left opening, a right upper electrode positioned above theright opening, and a right lower electrode positioned below the rightopening, the left opening and right opening configured to allow thepatient to have open eyes while electrical stimulation is delivered withthe plurality of electrodes; a pulse generator coupled to the pluralityof electrodes and containing electrical circuitry for issuing electricalstimuli using the plurality of electrodes; and a controller containingcommunication circuitry for wirelessly communicating with the pulsegenerator and programming the electrical circuitry for issuing theelectrical stimuli.
 2. The system of claim 1 further comprising a strapattached to the mask and positioned to wrap around the head of thepatient and hold the mask in a desired position on the face of thepatient.
 3. The system of claim 2 wherein the pulse generator is carriedon the mask.
 4. The system of claim 1 wherein the mask is formed of aflexible material.
 5. The system of claim 1 wherein the mask comprises amalleable nosepiece.
 6. The system of claim 1 wherein the plurality ofelectrodes consists of only the left upper electrode, the left lowerelectrode, the right upper electrode and the left lower electrode. 7.The system of claim 1 wherein the plurality of electrodes furtherincludes a return electrode for positioning on the skin of the patientat a position selected from the back of the neck, the shoulder, torso orlimb of the patient, and wherein the plurality of electrodes consists ofthe return electrode, the left upper electrode, the left lowerelectrode, the right upper electrode and the left lower electrode. 8.The system of claim 1 wherein the plurality of electrodes furtherincludes one or two return electrodes for positioning on the skin of thepatient at a position behind the ear or ears, and wherein the pluralityof electrodes consists of the one or two return electrodes, the leftupper electrode, the left lower electrode, the right upper electrode andthe left lower electrode.
 9. The system of claim 1 wherein each of theleft upper electrode, the left lower electrode, the right upperelectrode and the left lower electrode have a length of about 14 toabout 40 mm, and a width of about 10 to about 20 mm.
 10. The system ofclaim 1 wherein the pulse generator is coupled to the mask by a wire.11. The system of claim 1 wherein the pulse generator circuitry isconfigured to determine impedance encountered by issued stimuli.
 12. Thesystem of claim 1 wherein the pulse generator circuitry is configured toissue current controlled electrical stimulation with a frequency in therange of 10 Hz to 20 kHz, without a carrier signal.
 13. The system ofclaim 1 wherein the pulse generator is configured to issue electricalstimulation to test a phosphene threshold of the patient, and isprogrammed to issue electrical stimulation below the phosphene thresholdof the patient to avoid generating phosphenes during therapy.
 14. Thesystem of claim 1 wherein the pulse generator is configured to issueelectrical stimulation to test a phosphene threshold of the patient, andis programmed to issue electrical stimulation above the phosphenethreshold of the patient to thereby generate phosphenes during therapy.15. The system of claim 1 wherein the controller is configured toprogram the pulse generator with multiple therapy patterns.
 16. Thesystem of claim 1 wherein the controller is a mobile phone, tablet, orcomputer running an application for controlling the pulse generator. 17.The system of claim 1 wherein the controller communicates with the pulsegenerator using Bluetooth.
 18. A wearable device for providing therapyto a patient, the device comprising first and second treatment pads eachincluding an electrode configured to provide therapy to the patient'seyes, a frame configured to be worn on the patient's nose and extendingbetween and connecting the first and second treatment pads, and a firstbattery disposed within the first treatment pad and a second batterydisposed within the second treatment pad.
 19. The wearable device ofclaim 18, wherein the first and second batteries are rechargeable,wherein the wearable device further comprises a charging unit configuredto receive the first and second treatment pads to recharge the first andsecond batteries.
 20. A wearable device for providing therapy to apatient, the device comprising: a frame configured to be worn on thepatient's face, the frame including a first and second earpiececonfigured to extend along each side of the patient's face and over thepatient's ears, and a bridge extending between the two earpieces andover the patient's nose; a plurality of prongs extending from the frame,each prong having a contact configured to contact skin of the patient'sface when the frame is in position on the patient's face; and aplurality of electrodes configured to provide therapy to the patient,one electrode disposed on each contact point.